The effect of synbiotics pomegranate juice on cardiovascular risk factors in PCOS patients: a randomized, triple-blinded, controlled trial Effect of synbiotic pomegranate juice on glycemic, sex hormone profile and anthropometric indices in PCOS: A randomized, triple blind, controlled trial. 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 The effects of synbiotic supplementation on hormonal status, biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial Consumption of Synbiotic Bread Decreases Triacylglycerol and VLDL Levels While Increasing HDL Levels in Serum from Patients with Type-2 Diabetes Failure of Synbiotic 2000 to Prevent Postoperative Recurrence of Crohn’s Disease Randomised clinical trial of synbiotic therapy in elective surgical patients
Purpose Polycystic ovarian syndrome ( PCOS ) is one of the most common metabolic and endocrine disorders . Functional foods like pomegranate and probiotics are those that are considered to have beneficial effects on metabolic diseases beyond their basic nutritional value . So , we aim ed to evaluate the effect of synbiotic pomegranate juice ( SPJ ) on cardiovascular risk factors on PCOS patients . Methods This was a r and omized , triple-blinded , 8-week trial . Participants were r and omly assigned to receive 300 mL/day of pomegranate juice ( PJ ) , synbiotic beverage ( SB ) , synbiotic pomegranate juice ( SPJ ) , or placebo beverage ( PB ) . Biochemical indices ( lipid profile , Total Antioxidant Capacity ( TAC ) , Malondialdehyde ( MDA ) , high sensitive C-Reactive Protein ( hs-CRP ) ) and blood pressure were assessed before and after the intervention . Results Participants in the PJ , SB , and SPJ groups experienced improvement in their lipid profile , oxidative stress , inflammation , and blood pressure during the time . Compared to placebo , Total Cholesterol ( TC ) was lower in the SB group ( P < 0.01 ) , LDL-c was lower in the SPJ and SB groups ( P < 0.01 ) , and HDL-c was higher in the SPJ and PJ groups ( P < 0.01 ) . With regards to oxidative stress and inflammation , when compared with placebo , MDA was lower in the SPJ , SB , and PJ groups ( P < 0.001 ) , TAC was increased in the SPJ and PJ groups ( P $ $ < $ $ < 0.001 ) , and hs-CRP was decreased in the PJ group ( P = 0.02 ) . Blood pressure ( BP ) was lower in the SPJ and PJ groups compared to placebo ( P < 0.001 ; P < 0.01 , respectively ) . Conclusions Consuming daily SPJ for 8 weeks improved metabolic , oxidative , inflammatory , and BP outcomes in females with PCOS . This trial was registered in the Iranian Registry of Clinical Trials ( I RCT 20170207032439N2 ) BACKGROUND AND AIMS Polycystic Ovarian Syndrome is a common reproductive , endocrine , and metabolic disease in women .  Pomegranate juice , known as a rich source of phytochemicals with high antioxidant activity , enriched with probiotic may improve PCOS . METHODS AND RESULTS A r and omized , controlled , triple-blinded , parallel trial study was performed in PCOS patients ( n = 92 ) . Three treatment groups ( 23 patients each ) received 2 L of synbiotic pomegranate juice ( SPJ ) , pomegranate juice ( PJ ) , and synbiotic beverage ( SB ) weekly . The control group ( 23 patients ) received 2 L of placebo beverage weekly . Primary outcome was any change in insulin resistance and secondary outcomes were fasting blood sugar ( FBS ) , insulin sensitivity , testosterone , luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , body mass index ( BMI ) , waist and hip circumference , from baseline to the end of the trial . At the end of the study , 86 patients were analyzed . There was significant change in insulin resistance in the SPJ and SB groups . Insulin sensitivity increased significantly in the SPJ and SB groups . Insulin also changed significantly in the SPJ and SB groups . BMI , weight and waist circumference decreased significantly in the SPJ and SB groups . Testosterone level also decreased significantly in the SPJ and SB groups . There was no significant change in FPG , LH and FSH in any of the groups . CONCLUSION SPJ in the form of a new beverage can improve insulin resistance , insulin , testosterone level , BMI , weight and waist circumference in PCOS . This trial was registered in Iranian Registry of Clinical Trials , with number : 25272 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 Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27 To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13 Complications of Crohn ’s disease ( CD ) lead to surgery in about 70–90 % of patients . The majority of patients suffer from relapse of the disease . Colonic bacteria are essential to the development of CD . Therefore , a rationale exists in trying to prevent relapse by manipulation of gut microflora . This is feasible by treatment with probiotics or antibiotics . Synbiotic 2000 is a cocktail containing 4 probiotic species and 4 prebiotics . It is rational to pursue that it could be effective in preventing postoperative disease . We sought to check weather treatment with Synbiotic 2000 could prevent postoperative recurrence in patients with CD . This was a prospect i ve multicenter , r and omized study . Patients were r and omized to active treatment or placebo in a 2:1 ratio . Follow-up consisted of endoscopic , clinical , and laboratory parameters . Thirty patients were enrolled . No differences were found between the 2 treatment groups regarding gender , age at diagnosis , age at surgery , weight , smoking status , type of disease , length of the resected segment , or medical treatment prior to surgery . No difference in either endoscopic or clinical relapse rate was found between patients treated with once daily dose of Synbiotic 2000 or placebo . In our small study , Synbiotic 2000 had no effect on postoperative recurrence of patients with CD . Larger studies in patients with the inflammatory type of CD undergoing surgery , using higher doses of probiotics cocktail might prove effective Background : It is possible to manipulate the composition of the gastrointestinal microflora by administration of pre- and probiotics . This may help to preserve gut barrier function and reduce the incidence of septic morbidity . Aims : To assess the effects of a combination of pre- and probiotics ( synbiotic ) on bacterial translocation , gastric colonisation , systemic inflammation , and septic morbidity in elective surgical patients . Patients : Patients were enrolled two weeks prior to elective abdominal surgery . Seventy two patients were r and omised to the synbiotic group and 65 to the placebo group . Patients were well matched regarding age and sex distribution , diagnoses , and POSSUM scores . Methods : Patients in the synbiotic group received a two week preoperative course of Lactobacillus acidophilus La5 , Bifidobacterium lactis Bb-12 , Streptococcus thermophilus , and Lactobacillus bulgaricus , together with the prebiotic oligofructose . Patients in the placebo group received placebo capsules and sucrose powder . At surgery , a nasogastric aspirate , mesenteric lymph node , and scrapings of the terminal ileum were harvested for microbiological analysis . Serum was collected preoperatively and on postoperative days 1 and 7 for measurement of C reactive protein , interleukin 6 , and antiendotoxin antibodies . Septic morbidity and mortality were recorded . Results : There were no significant differences between the synbiotic and control groups in bacterial translocation ( 12.1 % v 10.7 % ; p = 0.808 , χ2 ) , gastric colonisation ( 41 % v 44 % ; p = 0.719 ) , systemic inflammation , or septic complications ( 32 % v 31 % ; p = 0.882 ) . Conclusions : In this study , synbiotics had no measurable effect on gut barrier function in elective surgical patients . Further studies investigating the place of pre- and probiotics in clinical practice are required
The administration of probiotic/synbiotic were associated with a significant improvement in FPG , FBI , HOMA I-R , BMI .
It also modified Ferriman-Gallway , serum triglycerides , serum testosterone , hs-CRP , NO , TAC , GSH , and MDA .
Subgroup analysis of the type of intervention showed that probiotics were associated with greater testosterone and FPG reduction ;  synbiotics administration result ed in a more pronounced decrease of the FBI .
Subgroup analyses on the duration of therapy showed that , probiotic/synbiotic administration had a significantly greater effect on QUICK-I in the case of women with 12-weeks of therapy than in the 8-weeks therapy group .
Nevertheless , we did not observe any significant difference was observed in terms of FBI , HOMA-IR , and FPG .
Probiotics and synbiotics seem to either an effect on/influence metabolic , hormonal and inflammatory parameters , or can influence them .
Consequently , it could lead to an improvement of fertility in PCOS
Several r and omized controlled trials ( RCTs ) have investigated the use of probiotic/synbiotic in PCOS patients , without clarifying the real use in clinical practice .
The aim of this meta- analysis was to evaluate the effectiveness of probiotics and synbiotics on metabolic , hormonal and inflammatory parameters of PCOS  .