Effect of vitamin D supplementation on inflammation: protocol for a systematic review Effects of Probiotics on Biomarkers of Oxidative Stress and Inflammatory Factors in Petrochemical Workers: A Randomized, Double-blind, Placebo-controlled Trial World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Probiotics Nutritional Intervention as a Preventive Approach for Cognitive-Related Outcomes in Cognitively Healthy Older Adults: A Systematic Review. The effects of probiotic and selenium co-supplementation on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome A systematic review protocol examining the effect of vitamin D supplementation on endothelial function Effects of a Multispecies Probiotic Supplement on Bone Health in Osteopenic Postmenopausal Women: A Randomized, Double-blind, Controlled Trial Efficacy of vitamin D supplementation in depression in adults: a systematic review protocol A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) Overview of Reviews The prevention of eczema in infants and children: an overview of Cochrane and non-Cochrane reviews. Effects of Probiotic Supplementation on Hormonal Profiles, Biomarkers of Inflammation and Oxidative Stress in Women With Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. Probiotic Therapy of the Irritable Bowel Syndrome: Why Is the Evidence Still Poor and What Can Be Done About It? World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Prebiotics Examining the theory‐effectiveness hypothesis: A systematic review of systematic reviews INVITED COMMENTARY: Rating the Quality of Trials in Systematic Reviews of Physical Therapy Interventions The politics of probiotics: probiotics, necrotizing enterocolitis and the ethics of neonatal research Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial Summarizing systematic reviews: methodological development, conduct and reporting of an umbrella review approach Are non-steroidal anti-inflammatory drugs effective for the management of neck pain and associated disorders, whiplash-associated disorders, or non-specific low back pain? A systematic review of systematic reviews by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. A human, double-blind, placebo-controlled, crossover trial of prebiotic, probiotic, and synbiotic supplementation: effects on luminal, inflammatory, epigenetic, and epithelial biomarkers of colorectal cancer. Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol Effects of Multistrain Probiotic Supplementation on Glycemic and Inflammatory Indices in Patients with Nonalcoholic Fatty Liver Disease: A Double-Blind Randomized Clinical Trial Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial The effects of probiotic supplementation on biomarkers of inflammation, oxidative stress and pregnancy outcomes in gestational diabetes The effects of probiotic supplement on hemoglobin in chronic renal failure patients under hemodialysis: A randomized clinical trial Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey Impact of probiotic Lactobacillus plantarum TENSIA in different dairy products on anthropometric and blood biochemical indices of healthy adults. Supplementation of Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 in Diet-Induced Obese Mice Is Associated with Gut Microbial Changes and Reduction in Obesity Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials Systematic review automation technologies
Introduction The extraskeletal role of vitamin D is being increasingly recognised . This has important clinical implication s , as vitamin D deficiency has reached epidemic proportions worldwide . Vitamin D has proposed anti-inflammatory properties , yet the role of vitamin D supplementation in reducing inflammation remains largely unknown . The purpose of this review is to investigate the impact of vitamin D supplementation on inflammation , and to identify relevant knowledge gaps in the field . Methods and analysis Medline , CINAHL , EMBASE and All EBM will be systematic ally search ed for r and omised controlled trials ( RCTs ) and systematic review s of RCTs , comparing vitamin D supplementation with placebo , usual care or other pharmacological or non-pharmacological interventions . One review er will assess articles for eligibility according to prespecified selection criteria , after which 2 independent review ers will perform data extraction and quality appraisal . Meta-analyses will be conducted where appropriate . Ethics and dissemination Formal ethical approval is not required as no primary data is collected . This systematic review will identify potential clinical implication s of vitamin D deficiency and supplementation , and will be disseminated through a peer- review ed publication and at conference meetings , to inform future research on the efficacy of vitamin D supplementation for inflammation and inflammatory diseases . PROSPERO registration number CRD42016037104 Background : The aim of the current study was to determine effects of probiotic yoghurt and multispecies probiotic capsule supplementation on biomarkers of oxidative stress and inflammatory factors in petrochemical workers . Methods : This r and omized , double-blind , placebo-controlled trial was done among petrochemical workers . Subjects were r and omly divided into three groups to receive 100 g/day probiotic yogurt ( n = 12 ) or one probiotic capsule daily ( n = 13 ) or 100 g/day conventional yogurt ( n = 10 ) for 6 weeks . The probiotic yoghurt was containing two strains of Lactobacillus acidophilus and Bifidobacterium lactis with a total of min 1 × 107 CFU . Multispecies probiotic capsule contains seven probiotic bacteria spices Actobacillus casei 3 × 103 , L. acidophilus 3 × 107 , Lactobacillus rhamnosus 7 × 109 , Lactobacillus bulgaricus 5 × 108 , Bifidobacterium breve 2 × 1010 , Bifidobacterium longum 1 × 109 and Streptococcus thermophilus 3 × 108 CFU/g . Fasting blood sample s were obtained at the beginning and end of the trial to quantify biomarkers of oxidative stress and inflammatory factors . Results : Although a significant within-group decrease in plasma protein carbonyl levels was seen in the probiotic capsule group ( 326.0 ± 308.9 vs. 251.0 ± 176.3 ng/mL , P = 0.02 ) , the changes were similar among the three groups . In addition , significant within-group decreases in plasma iso prostagl and in were observed in the probiotic supplements group ( 111.9 ± 85.4 vs. 88.0 ± 71.0 pg/mL , P = 0.003 ) and in the probiotic yogurt group ( 116.3 ± 93.0 vs. 92.0 ± 66.0 pg/mL , P = 0.02 ) , nevertheless there were no significant change among the three groups . Conclusions : Taken together , consumption of probiotic yogurt or multispecies probiotic capsule had beneficial effects on biomarkers of oxidative stress in petrochemical workers Background Prevalence of  allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Probiotics have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of probiotics in the prevention of allergy . Methods We identified the most relevant clinical questions and performed a systematic review of r and omized controlled trials of probiotics for the prevention of allergy . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . We search ed for and review ed the evidence about health effects , patient values and preferences , and re source use ( up to November 2014 ) . We followed the GRADE evidence -to-decision framework to develop recommendations . Results Currently available evidence does not indicate that probiotic supplementation  reduces the risk of developing allergy in children . However , considering all critical outcomes in this context , the WAO guideline panel determined that there is a likely net benefit from using probiotics result ing primarily from prevention of eczema . The WAO guideline panel suggests : a ) using probiotics in pregnant women at high risk for having an allergic child ; b ) using probiotics in women who breastfeed infants at high risk of developing allergy ; and c ) using probiotics in infants at high risk of developing allergy . All recommendations are conditional and supported by very low quality evidence . Conclusions WAO recommendations about probiotic supplementation for prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether to use probiotics in pregnancy and during breastfeeding , and whether to give them to infants The link diet-cognitive function/dementia has been largely investigated in observational studies ; however , there was a lack of evidence from r and omized clinical trials ( RCTs ) on the prevention of late-life cognitive disorders though dietary intervention in cognitively healthy older adults . In the present article , we systematic ally review ed RCTs published in the last four years ( 2014 - 2017 ) exploring nutritional intervention efficacy in preventing the onset of late-life cognitive disorders and dementia in cognitively healthy subjects aged 60 years and older using different levels of investigation ( i.e. , dietary pattern changes/medical food/nutraceutical supplementation/multidomain approach and dietary macro- and micronutrient approaches ) as well as possible underlying mechanisms of nutritional prevention . From the 35 included RCTs , there was moderate evidence that intervention through dietary pattern changes , medical food/nutraceutical supplementation , and multidomain approach improved specific cognitive domains or cognitive-related blood biomarkers . There was high evidence that protein supplementation improved specific cognitive domains or functional status in prefrail older adults without effect on cognitive function . For fatty acid supplementation , mainly long-chain polyunsaturated fatty acids , there was emerging evidence suggesting an impact of this approach in improving specific cognitive domains , magnetic resonance imaging ( MRI ) findings , and /or cognitive-related biomarkers also in selected subgroups of older subjects , although some results were conflicting . There was convincing evidence of an impact of non-flavonoid polyphenol and flavonoid supplementations in improving specific cognitive domains and /or MRI findings . Finally , there was only low evidence suggesting efficacy of intervention with homocysteine-related and antioxidant vitamins in improving cognitive functions , dementia incidence , or cognitive-related biomarkers in cognitively healthy older subjects Background The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health , hormonal profiles , and biomarkers of inflammation and oxidative stress in women with PCOS . Data on the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters of patients with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health , hormonal and inflammatory parameters in women with PCOS . Methods This r and omized , double-blinded , placebo-controlled clinical trial was conducted on 60 subjects , aged 18–40 years old . Participants were r and omly allocated into two groups to intake 8 × 109 CFU/day probiotic plus 200 μg/day selenium supplements ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Hormonal and inflammatory parameters were measured at baseline and after the 12-week intervention . Results Probiotic and selenium co-supplementation result ed in a significant improvement in beck depression inventory ( β − 0.76 ; 95 % CI , − 1.26 , − 0.26 ; P = 0.003 ) , general health question naire scores ( β − 1.15 ; 95 % CI , − 1.97 , − 0.32 ; P = 0.007 ) and depression anxiety and stress scale scores ( β − 1.49 ; 95 % CI , − 2.59 , − 0.39 ; P = 0.009 ) compared with the placebo . Furthermore , probiotic and selenium co-supplementation  significantly reduced total testosterone ( β − 0.26 ng/mL ; 95 % CI , − 0.51 , − 0.02 ; P = 0.03 ) , hirsutism ( β − 0.43 ; 95 % CI , − 0.74 , − 0.11 ; P = 0.008 ) , high-sensitivity C-reactive protein ( hs-CRP ) ( β − 0.58 mg/L ; 95 % CI , − 0.97 , − 0.19 ; P = 0.004 ) and malondialdehyde ( MDA ) levels ( β − 0.29 μmol/L ; 95 % CI , − 0.56 , − 0.02 ; P = 0.03 ) , and significantly increased total antioxidant capacity ( TAC ) ( β + 84.76 mmol/L ; 95 % CI , + 48.08 , + 121.44 ; P < 0.001 ) and total glutathione ( GSH ) levels ( β + 26.78 μmol/L ; 95 % CI , + 4.33 , + 49.23 ; P = 0.02 ) compared with the placebo . Conclusions Overall , the co-administration of probiotic and selenium for 12 weeks to women with PCOS had beneficial effects on mental health parameters , serum total testosterone , hirsutism , hs-CRP , TAC , GSH and MDA levels . This study was prospect ively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( http://www.i rct .ir : I RCT 20170513033941N22).Trial registration I RCT 20170513033941N22 Introduction Vitamin D has potential benefits for extraskeletal health . These could include an anti-inflammatory effect as well as a reduction in endothelial dysfunction . We aim to provide quality evidence for the hypothesis that supplementation with vitamin D will improve endothelial function ( EF ) , possibly through the abrogation of systemic inflammation . Methods and analysis We will conduct a systematic review of all r and omised controlled trials on  vitamin D supplementation and EF lasting 12 weeks or more . The search will cover the period 2000–2015 and include studies that describe direct measures of EF  , markers of endothelial cell ( EC ) activation  and if concurrently reported , indicators of systemic inflammation  . Study selection will follow the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines and study quality will be assessed by the Jadad score in addition to an evaluation of allocation concealment and data analysis . If sufficient data are available , a meta- analysis will be conducted . The effect sizes will be generated using Hedges ’ g score , for both fixed and r and om effect models . I2 statistics and Galbraith plots will be used to assess heterogeneity and identify their potential sources . Potential publication and small sample size bias will be assessed by visual inspections of funnel plots and also Egger 's test . Meta-regression analysis ( if feasible ) will be conducted with restricted maximum likelihood ( REML ) estimation method , controlling for potential confounders ( demographics , study methods , location , etc ) . A backward elimination process will be applied in the regression modelling procedure . Subgroup analysis , conditional on number of studies retrieved and their sample size , will be stratified on participant disease category , total dose administered , degree of 25(OH)D change and type of supplement used . Ethics and dissemination Formal ethical approval is not required as primary data will not be collected . The results will be disseminated through a peer- review ed publication , conference presentation and the popular press . Trial registration number International Prospect i ve Register for Systematic Review s ( PROSPERO ) number CRD42014013523 ABSTRACT Objective : The development of alternative approaches to prevent and /or treat osteoporosis , as a chronic progressive bone disease , is being considered currently . Among dietary supplements , probiotics may have favorable effects on bone metabolism . Therefore , the aim of this study was to evaluate the effects of a multispecies probiotic supplementation on bone biomarkers and bone density in osteopenic postmenopausal women . Methods : This r and omized double-blind placebo-controlled clinical trial was performed on 50 patients with osteopenia aged 50–72 years . Participants were r and omly assigned to take either a multispecies probiotic supplement ( GeriLact ; n = 25 ) or placebo ( n = 25 ) for 6 months . GeriLact contains 7 probiotic bacteria species . Participants received 500 mg Ca plus 200 IU vitamin D  daily . Bone mineral density ( BMD ) of lumbar spine and total hip and blood biomarkers including bone-specific alkaline phosphatase ( BALP ) , osteocalcin ( OC ) , collagen type 1 cross-linked C-telopeptide ( CTX ) , deoxypyridinoline ( DPD ) , parathyroid hormone ( PTH ) , 25-OH vitamin D , and serum pro-inflammatory cytokines ( tumor necrosis factor [TNF]-α and interleukin [IL]-1β ) were assessed at baseline and at the end of the study . Results : The multispecies probiotic significantly decreased BALP ( p = 0.03 ) and CTX ( p = 0.04 ) levels in comparison with the control group but had no effect on BMD of the spine and total hip . Moreover , there was a statistically significant decrease in serum PTH ( p = 0.01 ) and TNF-α ( p = 0.02 ) in the intervention group compared to the placebo group . Conclusions : These results may suggest the favorable effects of the multispecies probiotic supplementation for 6 months on bone health in postmenopausal women due to slowing down the rate of bone turnover Background The role of vitamin D in management of depression is unclear . Results from observational and emerging r and omized controlled trials ( RCTs ) investigating the efficacy of vitamin D in depression lack consistency - with some suggesting a positive association while others show a negative or inconclusive association . Methods / Design The primary aim of this study is to conduct a systematic review of RCTs to assess the effect of oral vitamin D supplementation versus placebo on depression symptoms measured by scales and the proportion of patients with symptomatic improvement according to the authors ’ original definition . Secondary aims include assessing the change in quality of life , adverse events and treatment discontinuation . We will conduct the systematic review and meta- analysis according to the recommendations of the Cochrane H and book for Systematic Review s of Interventions . We will search the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE ( 1966 to present ) , EMBASE ( 1980 to present ) , CINAHL ( 1982 to present ) , PsychINFO ( 1967 to present ) and Clinical Trials.gov . Unpublished work will be identified by search ing two major conferences : the International Vitamin Conference , the Anxiety Disorders and Depression Conference , while grey literature will be acquired by contacting authors of included studies . We will use the r and om-effects meta- analysis to synthesize the data by pooling the results of included studies . Discussion The results of this systematic review will be helpful in clarifying the efficacy of vitamin D supplementation and providing evidence to establish guidelines for implementation of vitamin D for depression in general practice and other relevant setting s. Study registration Unique identifier : CRD42013003849 Gastrointestinal ( GI ) symptoms and irritable bowel ( IB ) symptoms have been associated with chronic fatigue syndrome/myalgic encephalomyelitis ( CFS/ME ) . The aim of this study was to conduct a systematic review of these symptoms in CFS/ME , along with any evidence for probiotics as treatment . Pubmed , Scopus , Medline ( EBSCOHost ) and EMBASE data bases were search ed to source relevant studies for CFS/ME . The review included any studies examining GI symptoms , irritable bowel syndrome ( IBS ) and /or probiotic use . Studies were required to report criteria for CFS/ME and study design , intervention and outcome measures . Quality assessment was also completed to summarise the level of evidence available . A total of 3381 publications were returned using our search terms . Twenty-five studies were included in the review . R and omised control trials were the predominant study type ( n = 24 ) . Most of the studies identified examined the effect of  probiotic supplementation on the improvement of IB symptoms in IBS patients , or IB symptoms in CFS/ME patients , as well as some other significant secondary outcomes ( e.g. quality of life , other gastrointestinal symptoms , psychological symptoms ) . The level of evidence identified for the use of  probiotics  in IBS was excellent in quality ; however , the evidence available for the use of probiotic interventions in CFS/ME was poor and limited . There is currently insufficient evidence for the use of probiotics in CFS/ME patients , despite probiotic interventions being useful in IBS . The studies pertaining to probiotic interventions in CFS/ME patients were limited and of poor quality overall . St and ardisation of protocol s and methodology in these studies is required BACKGROUND : Eczema is the most common inflammatory skin disease of childhood , characterized by an itchy red rash that usually involves the face and skin folds . There is currently no curative treatment for eczema , so the reduction of eczema incidence through disease prevention is a desirable goal . Potential interventions for preventing eczema include exclusive breastfeeding , hydrolysed protein formulas and soy formulas when bottle feeding , maternal antigen avoidance , omega oil supplementation , prebiotics and probiotics . OBJECTIVES : This overview of review s aims to present the current body of data from Cochrane and non-Cochrane review s to provide the most up-to- date evidence on the efficacy and safety of interventions to prevent eczema in infants and children at different risk levels for developing allergic disease . METHODS : Our pool of Cochrane and non-Cochrane review s came from the 2010 United Kingdom National Health Service ( NHS ) Evidence Skin Disorders Annual Evidence Up date s Mapping Exercise on Atopic Eczema . This group used a comprehensive search strategy last conducted in August 2010 to identify all systematic review s on eczema prevention . We identified all review s that met our pre-specified inclusion criteria , and data were extracted , analysed , compiled into tables and synthesized using quantitative and qualitative methods . MAIN RESULTS : Seven systematic review s containing 39 relevant trials with 11 897 participants were included in this overview . Overall , there was no clear evidence that any of the main interventions review ed reduced eczema incidence . In subgroup analyses of infants at high risk of allergic disease , an observational study found that exclusive breastfeeding for at least six months compared with introduction of solids at three to six months decreased the incidence of eczema by 60 % ( risk ratio ( RR ) : 0.40 ; 95 % confidence interval ( CI ) : 0.21 , 0.78 ) , and a r and omized controlled trial found that prebiotics compared with no prebiotics  decreased incidence by 58 % ( RR : 0.42 ; 95 % CI : 0.21 , 0.84 ) . However , each of these findings was based on the results of a single small trial , and no intervention reduced eczema incidence beyond the first two years of life . Although we pre-specified incidence of atopic eczema ( i.e. eczema associated with immunoglobulin E ( IgE ) sensitization ) as a primary outcome , data on whether participants diagnosed with eczema were truly atopic were largely lacking from systematic review s. Similarly , data on atopy , measured using skin prick tests or specific IgE tests to allergens , were not reported in many review s. No interventions were found to decrease atopy when reported . Adverse events data were generally lacking , but data from a trial of probiotics versus no probiotics showed significantly more spitting up in the first one ( RR : 1.88 ; 95 % CI : 1.03 , 3.45 ) and two ( RR : 1.69 ; 95 % CI : 1.02 , 2.80 ) months of life , but no overall increase in risk of gastrointestinal symptoms in the first year . AUTHORS # ENTITYSTARTX02019 ; CONCLUSIONS : Although there is currently no clear evidence showing that any of the interventions examined in this overview prevent eczema in participants not selected for risk of allergic disease , there is some evidence that exclusive breastfeeding for at least six months and prebiotics might reduce eczema incidence in high-risk participants . However , these conclusions are based on limited evidence with method ological shortcomings . Future research on prevention of eczema is needed and should examine different types of hydrolysed formulas , prebiotics and probiotics , as well as enhancement of the skin barrier and other novel approaches in infants at different risk levels for developing allergic disease BACKGROUND To the best of our knowledge , data on effects of probiotic administration on hormonal profiles , biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles , biomarkers of inflammation and oxidative stress in women with PCOS . METHODS This r and omized , double-blind , placebo-controlled trial was conducted on 60 women with PCOS , aged 18 - 40 years old . Subjects were r and omly assigned into 2 groups to receive either probiotics or placebo ( n = 30 each group ) for 12 weeks . Metabolic profiles were quantified at baseline and after a 12-week intervention . RESULTS After the 12-week intervention , compared with placebo , probiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( + 25.9 ± 32.5 vs. + 0.5 ± 15.6 nmol/L , P < 0.001 ) and plasma total antioxidant capacity ( TAC ) ( + 8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L , P = 0.04 ) , and significantly decreased serum total testosterone ( -0.2 ± 0.7 vs. + 0.2 ± 0.6 ng/mL , P = 0.03 ) , modified Ferriman-Gallwey ( mF-G ) scores ( -1.7 ± 1.5 vs. -0.2 ± 1.0 , P < 0.001 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( -1150.0 ± 1295.2 vs. + 202.5 ± 1426.3 ng/mL , P < 0.001 ) and plasma malondialdehyde ( MDA ) concentrations ( -0.2 ± 0.6 vs. + 0.9 ± 1.3 µmol/L , P < 0.001 ) . We did not observe any detrimental effect of probiotic supplementation on other metabolic profiles . CONCLUSION Overall , probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone , SHBG , mFG scores , hs-CRP , TAC and MDA levels but did not affect other metabolic profiles OBJECTIVE This study was conducted to develop evidence -based clinical practice guidelines for nutrition support ( ie , enteral and parenteral nutrition ) in mechanically ventilated critically ill adults . OPTIONS The following interventions were systematic ally review ed for inclusion in the guidelines : enteral nutrition ( EN ) versus parenteral nutrition ( PN ) , early versus late EN , dose of EN , composition of EN ( protein , carbohydrates , lipids , immune-enhancing additives ) , strategies to optimize delivery of EN and minimize risks ( ie , rate of advancement , checking residuals , use of bedside algorithms , motility agents , small bowel versus gastric feedings , elevation of the head of the bed , closed delivery systems , probiotics , bolus administration ) , enteral nutrition in combination with supplemental PN , use of PN versus st and ard care in patients with an intact gastrointestinal tract , dose of PN and composition of PN ( protein , carbohydrates , IV lipids , additives , vitamins , trace elements , immune enhancing substances ) , and the use of intensive insulin therapy . OUTCOMES The outcomes considered were mortality ( intensive care unit [ ICU ] , hospital , and long-term ) , length of stay ( ICU and hospital ) , quality of life , and specific complications . EVIDENCE We systematic ally search ed MEDLINE and CINAHL ( cumulative index to nursing and allied health ) , EMBASE , and the Cochrane Library for r and omized controlled trials and meta-analyses of r and omized controlled trials that evaluated any form of nutrition support in critically ill adults . We also search ed reference lists and personal files , considering all articles published or unpublished available by August 2002 . Each included study was critically appraised in duplicate using a st and ard scoring system . VALUES For each intervention , we considered the validity of the r and omized trials or meta-analyses , the effect size and its associated confidence intervals , the homogeneity of trial results , safety , feasibility , and the economic consequences . The context for discussion was mechanically ventilated patients in Canadian ICUs .  BENEFITS , HARMS , AND COSTS The major potential benefit from implementing these guidelines is improved clinical outcomes of critically ill patients ( reduced mortality and ICU stay ) . Potential harms of implementing these guidelines include increased complications and costs related to the suggested interventions . SUMMARIES OF EVIDENCE AND RECOMMENDATIONS : When considering nutrition support in critically ill patients , we strongly recommend that EN be used in preference to PN . We recommend the use of a st and ard , polymeric enteral formula that is initiated within 24 to 48 hours after admission to ICU , that patients be cared for in the semirecumbent position , and that arginine-containing enteral products not be used . Strategies to optimize delivery of EN ( starting at the target rate , use of a feeding protocol using a higher threshold of gastric residuals volumes , use of motility agents , and use of small bowel feeding ) and minimize the risks of EN ( elevation of the head of the bed ) should be considered . Use of products with fish oils , borage oils , and antioxidants should be considered for patients with acute respiratory distress syndrome . A glutamine-enriched formula should be considered for patients with severe burns and trauma . When initiating EN , we strongly recommend that PN not be used in combination with EN . When PN is used , we recommend that it be supplemented with glutamine , where available . Strategies that maximize the benefit and minimize the risks of PN ( hypocaloric dose , withholding lipids , and the use of intensive insulin therapy to achieve tight glycemic control ) should be considered . There are insufficient data to generate recommendations in the following areas : use of indirect calorimetry ; optimal pH of EN  ; supplementation with trace elements , antioxidants , or fiber ; optimal mix of fats and carbohydrates ; use of closed feeding systems ; continuous versus bolus feedings ; use of probiotics ; type of lipids ; and mode of lipid delivery . VALIDATION This guideline was peer- review ed and endorsed by official representatives of the Canadian Critical Care Society , Canadian Critical Care Trials Group , Dietitians of Canada , Canadian Association of Critical Care Nurses , and the Canadian Society for Clinical Nutrition . SPONSORS This guideline is a joint venture of the Canadian Critical Care Society , the Canadian Critical Trials Group , the Canadian Society for Clinical Nutrition , and Dietitians of Canada . The Canadian Critical Care Society and the Institute of Nutrition , Metabolism , and Diabetes of the Canadian Institutes of Health Research provided funding for development of this guideline Background / Aims Despite numerous r and omized clinical trials and meta-analyses , there is no increased evidence for the efficacy of  probiotics  in the treatment of irritable bowel syndrome ( IBS ) . We review this evidence , identify and analyse the reasons for this lack of evidence and propose method ological improvements for future studies . Methods Based on a literature search , we identified 56 papers that matched the purpose of our analyses . Twenty-seven studies used multi-species bacterial preparations and 29 used single-strain probiotics . They were analysed regarding  patients included , treatment duration , probiotic dosage , and outcome measures . Results Trials in both groups suffered from heterogeneity with respect to probiotic concentration , duration of treatment , and other method ological issues ( crossover design and underpowered studies ) . This heterogeneity did not allow the application of a meta-analytic approach and a systematic review was therefore performed instead . Multi-strain preparations combined 2 to 8 different bacterial subspecies , mostly lactobacilli or bifidobacteria , and used variable lengths of treatments . Overall , more than 50 % of trials presented negative outcomes . The majority of the single-strain probiotic trials employing lactobacilli or Saccharomyces were negative , whereas trials employing bifidobacteria showed positive results . Conclusions The heterogeneity of the studies of probiotics in IBS questions the value of meta-analyses . The use of different bacterial strains and different mixtures of these strains , as well as different dosages , are the main contributors to this heterogeneity . Current data provides limited evidence for the efficacy of a small number of  single-strain probiotics  in IBS ( mostly bifidobacteria ) and sound studies following strict trial guidelines ( Food and Drug Administration and European Medicines Agency guidelines for clinical trials ) are needed . We summarised and proposed some method ological issues for future studies in the field Background The prevalence of allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Prebiotics – non-digestible oligosaccharides that stimulate growth of probiotic bacteria – have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of prebiotics in the prevention of allergy . Methods The WAO guideline panel identified the most relevant clinical questions about the use of prebiotics for the prevention of allergy . We performed a systematic review of r and omized controlled trials of prebiotics , and review ed the evidence about patient values and preferences , and re source requirements ( up to January 2015 , with an up date on July 29 , 2015 ) . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . Results Based on GRADE evidence to decision frameworks , the WAO guideline panel suggests using prebiotic supplementation in not-exclusively breastfed infants and not using prebiotic supplementation in exclusively breastfed infants . Both recommendations are conditional and based on very low certainty of the evidence . We found no experimental or observational study of prebiotic supplementation  in pregnant women or in breastfeeding mothers . Thus , the WAO guideline panel chose not to provide a recommendation about prebiotic supplementation in pregnancy or during breastfeeding , at this time . Conclusions WAO recommendations about prebiotic supplementation for the prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether or not to use prebiotics for the purpose of preventing allergies in healthy , term infants PURPOSE Health interventions based on theory may be more effective than those that are not . This review of review s synthesizes all published r and omized controlled trial ( RCT ) meta-analytic evidence from the last decade to examine whether theory-based interventions were found to be associated with more effective  adult health behaviour change interventions . METHODS Systematic review s including meta-analyses were identified by search ing Medline , CINAHL , PsycINFO , and CDSR . A narrative synthesis was used to summarize and analyse the evidence . Only review s including RCTs of health behaviour change interventions with adults aged 18 + published from 2007 to 2017 were included . RESULTS Of 8,659 articles , nine systematic review s met inclusion criteria . The majority of review s ( n = 8) suggested no increased effectiveness for theory-based compared to non-theory-based interventions for effectiveness of outcomes relating to health behaviour . Less than half of the RCTs included in the review s reported the use of theory ( 85/183 ) . Two review s suggested interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Method ological and reporting issues limit the conclusions . CONCLUSIONS Theory-based interventions as currently operationalized in systematic review s were not found to be more effective than non-theory-based interventions . Method ological and reporting issues at study and review level may not reflect the true utility of theory use within health behaviour interventions . The promotion of theory use may benefit from using a multifaceted argument , rather than a narrow focus of increased effectiveness . Statement of contribution What is already known on this subject ? Theory use is regularly promoted by cl aim ing that it will lead to more effective behaviour change interventions . Theory use has been frequently linked to effectiveness within systematic review s of behaviour change interventions . The theory-effectiveness hypothesis has not been systematic ally examined at the systematic review level . What does this study add ? Theory use as operationalized by systematic review authors was not associated with increased effectiveness within systematic review s examining r and omized controlled trials of behaviour change interventions in adults . Interventions based on control theory , motivational interviewing , or self-determination theory were associated with greater effectiveness for physical activity and /or dietary interventions and outcomes . Theory use should be promoted using a multifaceted argument , and assertions for increased effectiveness of theory-based interventions should only be used in domains where specific evidence exists to support this cl aim & NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a  cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy There have been over twenty prospect i ve , r and omized trials of the use of probiotics to prevent  necrotizing enterocolitis ( NEC ) in premature babies . A Cochrane meta- analysis of 16 of the studies ( 1 ) including 2842 preterm infants , reported that ‘ enteral probiotics supplementation significantly reduced the incidence of severe NEC ( stage II or more ) ( typical RR , 0.35 ; 95 % CI , 0.24–0.52 ) and mortality ( typical RR , 0.40 ; 95 % CI , 0.27–0.60 ) with no evidence of harm . They concluded , ‘ Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants ’ . In a sensitivity analysis , including only the 4 highest quality studies , the results and conclusions were unchanged . For neonates born at < 32 weeks of gestation , the number needed to treat in order to prevent one NEC or one death is twenty . The risks of probiotics are minimal . A more recently published systematic review included several additional r and omized controlled trials , mostly published in the Chinese literature , and analysed a total of 20 publications and over 3800 preterm infants ; it came to similar conclusions as the Cochrane meta- analysis ( 2 ) . Probiotics are used in many European units but only rarely in North-America . In spite of the evidence , this safe and effective treatment for one of the most serious complications of prematurity has never been studied in the United States and perhaps never will . Probiotics will probably never be approved by the U.S. Food and Drug Administration ( FDA ) . Instead , they will remain in regulatory purgatory , neither approved nor unapproved , an evidence -based treatment that can not become the st and ard of care , a safe and effective treatment that is not on hospital formularies in the United States . Probiotics fall into a peculiar lacuna of the regulatory system . Most innovative treatments are either drugs or devices , and the regulatory pathways for evaluating and approving them are fairly well defined by federal law . The FDA has jurisdiction over both drugs and devices . Probiotics are neither drugs nor devices , and they are made by companies that generally market health products to the general public . In contrast , in Canada , probiotics are under the jurisdiction of the Natural Health Products Directorate ( NHPD ) which has rigorous requirements for quality control and detailed labelling . But the NHPD does not evaluate overtly medical cl aims made about a product . It has little experience dealing with either a product that could actually decrease major complications or save lives in a particularly fragile population where mortality is rather common . Probiotics are quite inexpensive to manufacture . People can even make them at home . They are in most yogurts . For pennies , some parents buy them for their preterm infants in health food stores . Some mothers have started adding probiotics to their breast milk . In these cases , the medical team can either be unaware a preterm infant is in fact receiving probiotics or tacitly not interfere with these parental initiatives . Given the low cost of probiotics and Articles in the series A Different View are edited by William Meadow ( wlm1@uchicago.edu ) . We encourage you to offer your own different view either in response to A Different View you do not fully agree with , or on an unrelated topic . Send your article to Dr. Meadow ( wlm1@uchicago.edu ) Background Low grade chronic inflammation is observed in patients with type 2 diabetes mellitus ( T2DM ) . Endotoxin derived from gut bacteria may act as a potent inflammatory stimulant . Probiotics , which are believed to contain health promoting live microorganisms , may influence circulating endotoxin levels . Ingestion of live probiotic cultures may alter gut microbiota in a beneficial manner to reduce inflammation ; no information is available whether or not they do so in patients with T2DM . Therefore , the aim of this study is to characterize the beneficial effects of probiotics on circulating endotoxin levels and other biomarkers related to systemic low- grade inflammation in patients with T2DM . Methods One hundred and twenty consenting adult Saudi T2DM patients ( naïve or newly diagnosed and without co-morbidities ) will be enrolled in this clinical trial and r and omized to receive daily placebo or probiotics ( Ecologic ® Barrier ) for 26 weeks in a double-blind manner . Inflammatory and metabolic markers will be measured and fecal sample s analyzed . Measurements / sample s will be obtained at baseline and after 4 , 8 , 12/13 and 26 weeks of treatment . Discussion It is expected that the probiotic product will induce beneficial changes in gut microbiota , reduce the systemic inflammatory state through altering systemic endotoxin levels and , as such , reduce the systemic inflammatory response observed in T2DM subjects . Trial registration Clinical Trials.gov Identifier : Aims : With the increase in the number of systematic review s available , a logical next step to provide decision makers in healthcare with the evidence they require has been the conduct of review s of existing systematic review s. Syntheses of existing systematic review s are referred to by many different names , one of which is an umbrella review . An umbrella review allows the findings of review s relevant to a review question to be compared and contrasted . An umbrella review 's most characteristic feature is that this type of evidence synthesis only considers for inclusion the highest level of evidence , namely other systematic review s and meta-analyses . A methodology working group was formed by the Joanna Briggs Institute to develop method ological guidance for the conduct of an umbrella review , including diverse types of evidence , both quantitative and qualitative . The aim of this study is to describe the development and guidance for the conduct of an umbrella review . Methods : Discussion and testing of the elements of methods for the conduct of an umbrella review were held over a 6-month period by members of a methodology working group . The working group comprised six participants who corresponded via teleconference , e-mail and face-to-face meeting during this development period . In October 2013 , the methodology was presented in a workshop at the Joanna Briggs Institute Convention . Workshop participants , review authors and method ologists provided further testing , critique and feedback on the proposed methodology . Results : This study describes the methodology and methods developed for the conduct of an umbrella review that includes published systematic review s and meta-analyses as the analytical unit of the review . Details are provided regarding the essential elements of an umbrella review , including presentation of the review question in a Population , Intervention , Comparator , Outcome format , nuances of the inclusion criteria and search strategy . A critical appraisal tool with 10 questions to help assess risk of bias in systematic review s and meta-analyses was also developed and tested . Relevant details to extract from included review s and how to best present the findings of both quantitative and qualitative systematic review s in a reader friendly format are provided . Conclusions : Umbrella review s provide a ready means for decision makers in healthcare to gain a clear underst and ing of a broad topic area . The umbrella review methodology described here is the first to consider review s that report other than quantitative evidence derived from r and omized controlled trials . The methodology includes an easy to use and informative summary of evidence table to readily provide decision makers with the available , highest level of evidence relevant to the question posed Abstract Purpose To evaluate the effectiveness of non-steroidal anti-inflammatory drugs ( NSAIDs ) for the management of neck pain and associated disorders ( NAD ) , whiplash-associated disorders , and non-specific low back pain ( LBP ) with or without radiculopathy . Methods We systematic ally search ed six data bases from 2000 to 2014 . R and om pairs of independent review ers critically appraised eligible systematic review s using the Scottish Intercollegiate Guidelines Network criteria . We included systematic review s with a low risk of bias in our best evidence synthesis . Results We screened 706 citations and 14 systematic review s were eligible for critical appraisal . Eight systematic review s had a low risk of bias . For recent-onset NAD , evidence suggests that intramuscular NSAIDs lead to similar outcomes as combined manipulation and soft tissue therapy . For NAD ( duration not specified ) , oral NSAIDs may be more effective than placebo . For recent-onset LBP , evidence suggests that : ( 1 ) oral NSAIDs lead to similar outcomes to placebo or a muscle relaxant ; and ( 2 ) oral NSAIDs with bed rest lead to similar outcomes as placebo with bed rest . For persistent LBP , evidence suggests that : ( 1 ) oral NSAIDs are more effective than placebo ; and ( 2 ) oral NSAIDs may be more effective than acetaminophen . For recent-onset LBP with radiculopathy , there is inconsistent evidence on the effectiveness of oral NSAIDs versus placebo . Finally , different oral NSAIDs lead to similar outcomes for neck and LBP with or without radiculopathy . Conclusions For NAD , oral NSAIDs may be more effective than placebo . Oral NSAIDs are more effective than placebo for persistent LBP , but not for recent-onset LBP . Different oral NSAIDs lead to similar outcomes for neck pain and LBP OBJECTIVES Rheumatoid arthritis ( RA ) is an inflammatory autoimmune disease in which the gut microbiota is altered . Probiotics are microorganisms that can normalize gut microbiota ; thus , they may help to alleviate RA symptoms . The objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with RA . METHODS Forty-six patients with RA were assigned into two groups in this r and omized , double-blind , placebo-controlled clinical trial . The patients in the probiotic group received a daily capsule that contained a minimum of 10(8 ) colony-forming units of Lactobacillus casei 01 for 8 wk . The placebo group took capsules filled with maltodextrin for the same time period . Question naires , anthropometric measurements , and fasting blood sample s were collected , and the participants were assessed by a rheumatologist at baseline and at the end of the trial . RESULTS Disease activity score was significantly decreased by the intervention , and there was a significant difference between the two groups at the end of the study ( P < 0.01 ) . Three of the assessed serum proinflammatory cytokines ( tumor necrosis factor-α , interleukin-6 , and interleukin-12 ) significantly decreased in the probiotic group ( P < 0.05 ) ; however , serum levels of interleukin-1 β were not significantly affected by the probiotic ( P = 0.22 ) . The serum level of regulatory cytokine ( interleukin-10 ) was increased by the supplementation ( P < 0.05 ) . The proportion of interleukin-10 to interleukin-12 was significantly increased in the probiotic group as well . CONCLUSIONS L. casei 01 supplementation improved the disease activity and inflammatory status of patients with RA . Further studies are warranted to confirm these results , and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population BACKGROUND Diet is an important factor in colorectal carcinogenesis ; thus , dietary supplements may have a role in colorectal cancer prevention . OBJECTIVE The objective was to establish the relative luminal , epithelial , and epigenetic consequences of prebiotic , probiotic , and synbiotic dietary supplementation in humans . DESIGN This was a r and omized , double-blind , placebo-controlled , 4-wk crossover trial of resistant starch and Bifidobacterium lactis , either alone or as a combined synbiotic preparation , in 20 human volunteers . Rectal biopsy , feces , and serum sample s were collected . The rectal mucosal endpoints were DNA methylation at 16 CpG isl and loci and LINE-1 , epithelial proliferation ( Ki67 immunohistochemistry ) , and crypt cellularity . The fecal endpoints were short-chain fatty acid concentrations , pH , ammonia , and microbiological profiles ( by denaturing gradient gel electrophoresis and sequencing ) . Serum endpoints were a panel of cytokines and high-sensitivity C-reactive protein . RESULTS Seventeen subjects completed the entire study . The synbiotic intervention fostered a significantly different fecal stream bacterial community than did either the prebiotic ( P = 0.032 ) or the probiotic ( P = 0.001 ) intervention alone , in part because of a greater proportion of patients harboring fecal Lachnospiraceae spp . These changes developed in the absence of any significant differences in fecal chemistry . There were no differences in epithelial kinetics . CONCLUSIONS This synbiotic supplementation with B. lactis and resistant starch , in the doses used , induced unique changes in fecal microflora but did not significantly alter any other fecal , serum , or epithelial variables . This trial was registered in the Australian New Zeal and Clinical Trials Registry at www.anzctr.org.au as ACTRN012606000115538 Background Patients admitted to the intensive care unit with critical illness often experience significant physical impairments , which typically persist for many years following resolution of the original illness . Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit , following discharge to the ward and beyond hospital discharge . Multiple systematic review s have been published appraising the exp and ing evidence investigating these physical rehabilitation interventions , although there appears to be variability in review methodology and quality . We aim to conduct an overview of existing systematic review s of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery . Methods / design This protocol has been developed according to the Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol ( PRISMA -P ) guidelines . We will search the Cochrane Systematic Review Data base , Data base of Abstract s of Review s of Effectiveness , Cochrane Central Register of Controlled Trials , MEDLINE , Excerpta Medica Data base and Cumulative Index to Nursing and Allied Health Literature data bases . We will include systematic review s of r and omised controlled trials of adult patients , admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery . Data extraction will include systematic review aims and rationale , study types , population s , interventions , comparators , outcomes and quality appraisal method . Primary outcomes of interest will focus on findings reflecting recovery of physical function . Quality of reporting and method ological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Review s tool . Discussion We anticipate the findings from this novel overview of systematic review s will contribute to the synthesis and interpretation of existing evidence regarding physical rehabilitation interventions and physical recovery in post-critical illness patients across the continuum of recovery . Systematic review registration PROSPERO CRD42015001068 Objective : Nonalcoholic fatty liver disease ( NAFLD ) is a condition defined by exceeding triglycerides accumulation in the liver . The condition can develop into fibrosis , cirrhosis , and hepatocellular carcinoma . Considering the ever-increasing prevalence of NAFLD , the aim of the present study was to investigate the effects of probiotic supplementation on glycemic and inflammatory indices in patients with NAFLD . Methods : This r and omized clinical trial was conducted on 42 patients with NAFLD who had been referred to a gastroenterology clinic . Subjects in the intervention and control groups consumed 2 capsules/day probiotic or placebo , respectively , for 8 weeks . Fasting blood sugar ( FBS ) , insulin , insulin resistance , tumor necrosis factor alpha ( TNF-α ) , and interleukin 6 ( IL-6 ) were measured at baseline and at the end of the study . Results : Means of FBS , insulin , insulin resistance , and IL-6 were significantly different between groups after intervention ( p < 0.05 ) , whereas TNF-α was not significantly modified ( p > 0.05 ) . In the probiotic group , insulin , insulin resistance , TNF-α , and IL-6 decreased significantly at the end of the study compared to the beginning of study . Conclusion : Considering the effects of probiotic supplementation on the reduction of glycemic and inflammatory indices in patients with NAFLD , consumption of probiotics is recommended as a complementary therapy in these patients Background Bariatric surgery is known as one of the most effective treatments for sustainable weight loss ; however , it may be associated with some complications . This study was design ed to examine the effects of probiotic supplementation on some morbidities related to this surgery . Methods This was a placebo-controlled , double-blind , r and omized clinical trial on morbid obese patients referred for One Anastomosis Gastric Bypass- Mini Gastric Bypass ( OAGB-MGB ) surgery to a tertiary referral center . Patients were assigned to receive a probiotic supplement ( Familact ® ) or placebo from 4 weeks prior to surgery to 12 weeks after surgery . Anthropometric , biochemical , and inflammatory indices were evaluated at the beginning and the end of the study . Results At the end of study , significant improvements in some serum inflammatory markers , vitamin D status , and anthropometric measurements were observed ( p < 0.05 ) , which were significantly more in probiotic group rather than placebo group ( p < 0.05 ) . Moreover , significant improvements in glycemic indices and lipid profile were observed in both groups ; however , these changes were not significantly different between the groups . There was no significant difference in serum levels of vitamin B12 , folate , and homocysteine between groups at week 16 of the study . Discussion Our results indicate that probiotic supplementation promotes inflammatory markers , body weight loss , and status of vitamin D in patients undergoing OAGB-MGB bypass . Whether these findings will sustain in longer treatment duration remained to be eluci date d in future studies .Trial Registration This study has been registered at Clinical trial.gov with registration number NCT02708589 Abstract Objective : This study was design ed to evaluate the effects of probiotic supplementation on biomarkers of inflammation , oxidative stress and pregnancy outcomes  among subjects with gestational diabetes ( GDM ) . Methods : This r and omized , double-blind , placebo-controlled clinical trial was done among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly allocated to intake either probiotic capsule containing Lactobacillus acidophilus , Lactobacillus casei and Bifidobacterium bifidum ( 2 × 109 CFU/g each ) ( n = 30 ) or placebo ( n = 30 ) for six weeks . Results : Compared with the placebo , probiotic supplementation result ed in significant decreases in fasting plasma glucose ( FPG ) ( −5.3 ± 6.7 vs. + 0.03 ± 9.0 mg/dL , p = .01 ) , serum high-sensitivity C-reactive protein ( hs-CRP ) ( −2.2 ± 2.7 vs. + 0.5 ± 2.4 μg/mL , p < .001 ) , plasma malondialdehyde ( MDA ) concentrations ( −0.1 ± 0.8 vs. + 0.5 ± 1.5 μmol/L , p = .03 ) and MDA/TAC ratio ( −0.0003 ± 0.0008 vs. + 0.0009 ± 0.002 , p = .004 ) , and a significant increase in total antioxidant capacity ( TAC ) levels ( + 65.4 ± 103.3 vs. −37.2 ± 143.7 mmol/L , p = .002 ) . Probiotic supplementation did not affect pregnancy outcomes . Conclusions : Overall , probiotic supplementation among women with GDM for six weeks had beneficial effects on FPG , serum hs-CRP , plasma TAC , MDA and oxidative stress index , but did not affect pregnancy outcomes Background : Chronic inflammation is one of the causes of anemia in chronic renal failure patients under hemodialysis . Probiotics probably establish a balance between pro- and anti-inflammatory cytokines . The study was conducted to determine the effects of probiotic supplementation on hemoglobin ( Hb ) in hemodialysis patients . Material s and Methods : A parallel clinical trial was conducted in which patients were r and omly allocated into two groups . The intervention group ( n = 18 ) was given a 500 mg probiotic supplement ( a capsule ) every day whereas the  control group ( n = 18 ) received placebo ( a capsule ) , both for 3 months . Hb levels and C-reactive protein ( CRP ) levels were measured for three periods . The data were analyzed in SPSS-16 using statistical tests including the t-test and repeated- measures ANOVA . Results : In the probiotic supplementation group , the mean Hb was 9.22 ± 1.04 mg/dl before the intervention and reached 10.85 ± 1.177 mg/dl afterward , while in the placebo group , the mean Hb level was 9.38 ± 0.97 mg/dl before the intervention and reached 10.03 ± 1.97 mg/dl afterward ( P > 0.05 ) . During the study , the placebo caused to increase of Hb temporary , but in longer term , the effect of probiotic was more manifested . Hb levels increased in both groups although the change was not statistically significant ( P > 0.05 ) . The findings showed no significant differences between the two groups in either the pre- or post-intervention CRP levels ( P = 0.239 ) . Conclusion : Probiotic supplementation  decreased Hb fluctuations in hemodialysis patients but did not result in a significant increase in Hb levels . Similar studies are therefore recommended to be conducted with a prolonged duration of the study or an increased probiotic dose with larger sample size to complete the results of the present study Introduction Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) , the main forms of inflammatory bowel disease ( IBD ) , are chronic , progressive and disabling disorders of the gastrointestinal tract . Although data from r and omised controlled trials ( RCTs ) provide the foundation of evidence that vali date s medical therapy for IBD , considerable heterogeneity exists in the measured outcomes used in these studies . Furthermore , in recent years , there has been a paradigm shift in IBD treatment targets , moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance , inflammatory biomarkers and histological and radiographic end points . The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development . Accordingly , there exists a need to harmonise measures used in clinical trials through the development of a core outcome set ( COS ) . Methods and analysis The development of an IBD-specific COS includes four steps . First , a systematic literature review is performed to identify outcomes previously used in IBD RCTs . Second , semistructured qualitative interviews are conducted with key stakeholders , including patients , clinicians , research ers , pharmaceutical industry representatives , healthcare payers and regulators to identify additional outcomes of importance . Using the outcomes generated from literature review and stakeholder interviews , an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS . Finally , a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials . Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment , the design of robust clinical trials measuring relevant and st and ardised outcomes is crucial . St and ardising outcomes through a COS will reduce heterogeneity in trial reporting , facilitate valid comparisons of new therapies and improve clinical trial quality The blood pressure-lowering effect of dairy products holds the potential to decrease the risk of cardiovascular disease ( CVD ) . An open question is if the successful expression of functional properties of the probiotic strain depends on host biomarkers and /or food matrix properties . The probiotic Lactobacillus plantarum strain TENSIA ® ( DSM 21380 ) is a novel microorganism with antimicrobial and antihypertensive functional properties . The aim of this study was to characterise the functional properties of the probiotic L. plantarum TENSIA and compare its effects on host anthropometric , clinical , and blood biomarkers when consumed with cheese or yoghurt . This study involved two double-blinded r and omised placebo-controlled exploratory trials ( IS RCT N15061552 and IS RCT N79645828 ) of healthy adults over a three-week period . The three-week consumption of probiotic L. plantarum TENSIA in a daily dose of 1 × 1010 cfu in probiotic cheese or a daily dose of 6 × 109 cfu in yoghurt with different content of carbohydrates , proteins , and lipids did not significantly change the body mass index ( BMI ) , plasma glucose and lipid levels , or inflammatory markers in the blood . Reduced lowered systolic and diastolic blood pressure values were detected , regardless of food matrix or baseline values for blood pressure and BMI . In conclusion , our study showed that three-week consumption of the probiotic L. plantarum TENSIA either in cheese or yoghurt lowered diastolic and systolic blood pressure regardless of food matrix and baseline values of blood pressure and BMI , confirming the impact of the functional properties of the probiotic strain in decreasing CVD risk Objective To investigate the functional effects of probiotic treatment on the gut microbiota , as well as liver and adipose gene expression in diet-induced obese mice . Design Male C57BL/6J mice were fed a high-fat diet ( HFD ) for 8 weeks to induce obesity , and then r and omized to receive HFD+probiotic ( Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 , n = 9 ) or HFD+placebo ( n = 9 ) for another 10 weeks . Normal diet ( ND ) fed mice ( n = 9 ) served as non-obese controls . Results Diet-induced obese mice treated with probiotics showed reduced body weight gain and fat accumulation as well as lowered plasma insulin , leptin , total-cholesterol and liver toxicity biomarkers . A total of 151,061 pyrosequencing reads for fecal microbiota were analyzed with a mean of 6,564 , 5,274 and 4,464 reads for the ND , HFD+placebo and HFD+probiotic groups , respectively . Gut microbiota species were shared among the experimental groups despite the different diets and treatments . The diversity of the gut microbiota and its composition were significantly altered in the diet-induced obese mice and after probiotic treatment . We observed concurrent transcriptional changes in adipose tissue and the liver . In adipose tissue , pro-inflammatory genes ( TNFα , IL6 , IL1β and MCP1 ) were down-regulated in mice receiving probiotic treatment . In the liver , fatty acid oxidation-related genes ( PGC1α , CPT1 , CPT2 and ACOX1 ) were up-regulated in mice receiving probiotic treatment . Conclusions The gut microbiota of diet-induced obese mice appears to be modulated in mice  receiving probiotic treatment . Probiotic treatment might reduce diet-induced obesity and modulate genes associated with metabolism and inflammation in the liver and adipose tissue Objective Iron supplementation in iron-deficiency anaemia is st and ard practice , but the benefits of iron supplementation in iron-deficient non-anaemic ( IDNA ) individuals remains controversial . Our objective is to identify the effects of iron therapy on fatigue and physical capacity in IDNA adults . Design Systematic review and meta- analysis of r and omised controlled trials ( RCTs ) . Setting Primary care . Participants Adults ( ≥18 years ) who were iron deficient but non-anaemic . Interventions Oral , intramuscular or intravenous iron supplementation ; all therapy doses , frequencies and duration s were included . Comparators Placebo or active therapy . Results We identified RCTs in Medline , Embase , Cochrane Central Register of Controlled Trials , Cumulative Index of Nursing and Allied Health , SportD iscus and CAB Abstract s from inception to 31 October 2016 . We search ed the WHO ’s International Clinical Trials Registry Platform for relevant ongoing trials and performed forward search es of included trials and relevant review s in Web of Science . We assessed internal validity of included trials using the Cochrane Risk of Bias tool and the external validity using the Grading of Recommendations Assessment , Development and Evaluation methodology . From 11 580 citations , we included 18 unique trials and 2 companion papers enrolling 1170 patients . Using a Mantel-Haenszel r and om-effects model , iron supplementation was associated with reduced self-reported fatigue ( st and ardised mean difference ( SMD ) −0.38 ; 95 % CI −0.52 to −0.23 ; I2 0 % ; 4 trials ; 714 participants ) but was not associated with differences in objective measures of physical capacity , including maximal oxygen consumption ( SMD 0.11 ; 95 % CI −0.15 to 0.37 ; I2 0 % ; 9 trials ; 235 participants ) and timed methods of exercise testing  . Iron supplementation significantly increased serum haemoglobin concentration ( MD 4.01 g/L ; 95 % CI 1.22 to 6.81 ; I2 48 % ; 12 trials ; 298 participants ) and serum ferritin ( MD 9.23 µmol/L ; 95 % CI 6.48 to 11.97 ; I2 58 % ; 14 trials ; 616 participants ) . Conclusion In IDNA adults , iron supplementation is associated with reduced subjective measures of fatigue but not with objective improvements in physical capacity . Given the global prevalence of both iron deficiency and fatigue , patients and practitioners could consider consumption of iron-rich foods or iron supplementation to improve symptoms of fatigue in the absence of documented anaemia . PROSPERO registration number CRD42014007085 Systematic review s , a cornerstone of evidence -based medicine , are not produced quickly enough to support clinical practice . The cost of production , availability of the requisite expertise and timeliness are often quoted as major contributors for the delay . This detailed survey of the state of the art of information systems design ed to support or automate individual tasks in the systematic review , and in particular systematic review s of r and omized controlled clinical trials , reveals trends that see the convergence of several parallel research projects . We surveyed literature describing informatics systems that support or automate the processes of systematic review or each of the tasks of the systematic review . Several projects focus on automating , simplifying and /or streamlining specific tasks of the systematic review . Some tasks are already fully automated while others are still largely manual . In this review , we describe each task and the effect that its automation would have on the entire systematic review process , summarize the existing information system support for each task , and highlight where further research is needed for realizing automation for the task . Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow . We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials , appraises them , extracts and synthesizes data , evaluates the risk of bias , performs meta- analysis calculations , and produces a report in real time
Conclusions Probiotic supplementation significantly reduced serum concentrations of pro-inflammatory cytokines including , hs-CRP , TNF-a , IL-6 , IL-12 , and IL-4 , but it did not influence IL-1B , IL-8 , IFN-g , and IL-17 concentrations .
A significant increase in serum concentrations of IL-10 , as a anti-inflammatory cytokine was also documented after probiotic supplementation
Purpose No study has summarized earlier findings on the effect of probiotic supplementation on  inflammatory biomarkers .
This systematic review and meta- analysis was conducted to systematic ally review the available placebo-controlled clinical trials about the effect of probiotic supplementation  on several inflammatory biomarkers in adults .