Preventive effect of a Lactobacillus casei preparation on the recurrence of superficial bladder cancer in a double-blind trial. The BLP Study Group. A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation. Prevention of irinotecan induced diarrhea by probiotics: A randomized double blind, placebo controlled pilot study. A phase II study (ARCHER 1042) to evaluate prophylactic treatment of dacomitinib-induced dermatologic and gastrointestinal adverse events in advanced non-small-cell lung cancer. Prevention and management of chemotherapy-induced diarrhea in patients with colorectal cancer: a consensus statement by the Canadian Working Group on Chemotherapy-Induced Diarrhea Lactose intolerance associated with adjuvant 5-fluorouracil-based chemotherapy for colorectal cancer. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients Phase II randomized clinical trial of LC9018 concurrently used with radiation in the treatment of carcinoma of the uterine cervix. Its effect on tumor reduction and histology Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. The effects of perioperative probiotic treatment on serum zonulin concentration and subsequent postoperative infectious complications after colorectal cancer surgery: a double-center and double-blind randomized clinical trial. The prophylactic use of probiotics in the prevention of radiation therapy-induced diarrhea. Effects of probiotic Lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: results from multicenter, randomized, placebo-controlled nutritional trial. Effect of inulin and fructo-oligosaccharide on the prevention of acute radiation enteritis in patients with gynecological cancer and impact on quality-of-life: a randomized, double-blind, placebo-controlled trial Acute toxicity of whole-pelvis IMRT in 87 patients with localized prostate cancer A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. Results of a double-blind, randomized study to evaluate the efficacy and safety of Antibiophilus® in patients with radiation-induced diarrhoea Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures. Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: a randomised study
A double-blind trial was conducted in 138 patients with superficial transitional cell carcinoma of the bladder following transurethral resection to evaluate the prophylaxis of recurrence by an oral Lactobacillus casei preparation ( BLP ) . Patients were stratified into the following 3 subgroups : ( A ) with primary multiple tumors ; ( B ) with recurrent single tumors , and ( C ) with recurrent multiple tumors . In each group , patients were r and omly allocated to receive BLP or placebo . BLP showed a better prophylactic effect in subgroups A and B than placebo , whereas no significant difference was observed in subgroup C. Cox multivariate analysis showed that the outcome with BLP  was significantly better than with placebo ( p = 0.01 ) . Slight and tolerable adverse reactions occurred in 3 patients receiving BLP and in 3 of the placebo-treated patients . Oral administration of BLP was thus safe and effective for preventing recurrence of superficial bladder cancer BACKGROUND & AIMS Radical radiation therapy is commonly used for treatment of pelvic cancer . Up to 80 % of patients receiving radiotherapy will develop acute radiation induced diarrhea . The primary aim of this r and omized double blind controlled trial is to evaluate the effect of the probiotic Bifilact ( ® ) on moderate and severe treatment-induced diarrhea during pelvic radiation . METHODS Patients with pelvic cancers were treated between 2006 and 2010 at L'Hôtel-Dieu de Québec , University Health Center . Some patients had surgery before pelvic radiotherapy and some received chemotherapy .  A total of 246 Patients were r and omized between a placebo and either of two regiments of double strain Bifilact ( ® ) probiotics ( Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536 ) : a st and ard dose twice a day ( 1.3 billion CFU ) or a high dose three times a day ( 10 billion CFU ) . Patients were trained to record their digestive symptoms daily with a st and ardized scale and they met a registered dietician and radiation oncologist every week during treatment . The main analysis compared time to first appearance of grade ≥2 - 3 - 4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea . RESULTS 229 patients were analyzed . The difference between the groups for overall grade 2 - 3 - 4 diarrhea was not statistically significant ( p = 0.13 ) . However at 60 days , the proportion of patients without moderate and severe diarrhea in the st and ard dose group ( 35 % ) was more than twice as high as that of the placebo group ( 17 % ) with a hazard ratio of 0.69 ( p = 0.04 ) . In patients who had surgery , the st and ard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group , respectively 97 % and 74 % ( p = 0.03 ) . In all groups , the average number of bowel movements per day during treatment was less than 3 soft stools ( p = 0.80 ) and the median abdominal pain less than 1 based on the National Cancer Institute scale ( p = 0.23 ) . CONCLUSION St and ard dose of Bifilact ( ® ) may reduce radiation induced grade 2 - 3 - 4 diarrhea at the end of the treatment of patients with pelvic cancer . In patients operated on before RT , a st and ard dose of probiotics may reduce radiation induced grade 4 diarrhea . Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms . TRIAL REGISTRATION clinical trials.gov . Identifier NCT01839721 PURPOSE Diarrhea is one of the dose limiting toxicity of irinotecan . SN-38 is main irinotecan metabolite responsible for diarrhea development , which is excreted in glucuroni date d form into the intestine . This study aim ed to determine the effectiveness of the probiotics in the prevention of irinotecan induced diarrhea due to reduction of intestinal beta-d-glucuronidase activity . METHODS Between January 2011 and December 2013 , 46 patients with colorectal cancer starting a new line of irinotecan based therapy were included . Patients were r and omized 1:1 to probiotics ( PRO ) or placebo ( PLA ) . Probiotic formula Colon Dophilus ™ , was administered at a dose of 10 × 10(9)CFU of bacteria tid , orally for 12 weeks of chemotherapy . The study was prematurely terminated due to slow accrual , when 46 of 220 planned patients were accrued . RESULTS Twenty-three patients were r and omized to PRO and 23 patients to PLA . Administration of probiotics compared to placebo led to a reduction in the incidence of severe diarrhea of grade 3 or 4 ( 0 % for PRO vs. 17.4 % for PLA , p=0.11 ) , as well as reduction of the overall incidence of diarrhea ( 39.1 % for PRO vs. 60.9 % for PLA , p=0.24 ) and incidence of enterocolitis ( 0 % for PRO vs. 8.7 % for PLA ) . Patients on PRO  used less antidiarrheal drugs compared to PLA . There was no infection caused by probiotic strains recorded . CONCLUSIONS Administration of probiotics in patients with colorectal cancer treated with irinotecan-based chemotherapy is safe and could lead to a reduction in the incidence and severity of gastrointestinal toxicity BACKGROUND ARCHER 1042 , a r and omized phase II trial , explored the impact of prophylactic treatment on select dermatologic adverse events of interest ( SDAEI ) , diarrhea , and mucositis associated with dacomitinib , an oral irreversible pan-human epidermal growth factor receptor ( HER ) inhibitor , in development for advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with advanced NSCLC treated with dacomitinib were enrolled in two cohorts . Cohort I patients were r and omized 1:1 to receive oral doxycycline or placebo ( 4 weeks ) . Cohort II patients  received oral VSL#3 probiotic plus topical alclometasone . Primary end points for Cohorts I and II were incidence of all grade and grade ≥2 SDAEI in the first 8 weeks of treatment and quality of life ( QoL ) assessed by the Skindex-16 survey . Additional primary end points for Cohort II were incidence of all grade and grade ≥2 diarrhea and mucositis in the first 8 weeks of treatment ; QoL regarding diarrhea and mucositis incidence was assessed by the modified-Oral Mucositis Daily Question naire . RESULTS Cohort I r and omized 114 evaluable patients : 56 in the doxycycline arm , 58 in the placebo arm . Cohort II enrolled 59 evaluable patients .  Doxycycline significantly reduced the incidence of grade ≥2 SDAEI by 50 % ( P = 0.016 ) compared with placebo . The incidence of all grade SDAEI was lower with doxycycline than with placebo but did not reach statistical significance . Doxycycline was associated with less deterioration in QoL compared with placebo . Alclometasone was associated with less deterioration in QoL  compared with placebo but did not statistically significantly reduce the incidence of all grade or grade ≥2 SDAEI . VSL#3 did not reduce the incidence of all grade or grade ≥2 diarrhea and did not impact mucositis scores . CONCLUSIONS Doxycycline was effective as a prophylactic treatment for dacomitinib-induced grade ≥2 SDAEI . Both doxycycline and alclometasone reduced the negative impact in patient-reported dermatologic AEs . The probiotic was not effective for preventing diarrhea or mucositis Chemotherapy-induced diarrhea ( cid ) is a common side effect of cancer treatment and can cause significant morbidity and mortality . Diarrhea is frequently severe enough to require a dose reduction of , a delay in , or a discontinuation of chemotherapy . Diarrhea-associated mortality has been reported to be as high as 3.5 % in clinical trials of irinotecan and bolus 5-fluorouracil in colorectal cancer . The frequency of cid and its impact on patient management are frequently under-recognized in clinical practice . A Canadian working group , consisting of medical oncologists and an oncology pharmacist , was formed in 2001 to review the optimal approach to managing cid and to identify and implement new areas of research . The recommendations that follow are the result of the group ’s work . Acute medical management of cid includes loperamide or diphenoxylate as first-line agents . Subcutaneous octreotide is recommended for intractable grade 2 diarrhea and may be considered for grade 1 cid that does not resolve with high-dose loperamide . Hospitalization is recommended for patients with grade s 3 and 4 cid ; in-hospital care includes rehydration , antibiotic therapy , and octreotide . A chemotherapy dose reduction is generally advised for patients who have experienced grade 3 or 4 diarrhea in a previous chemotherapy cycle . If a dose reduction is not desired , prophylaxis with intramuscular long-acting release octreotide may be considered . The foregoing recommendations are based on expert opinion and require validation in prospect i ve clinical trials BACKGROUND & AIMS Bowel mucosal injury associated with 5-fluorouracil ( 5-FU ) treatment might result in secondary lactose intolerance . The frequency and clinical significance of 5-FU-related hypolactasia are unknown . METHODS One hundred fifty patients r and omly assigned to receive 1 of 2 adjuvant 5-FU-based chemotherapy regimens , the Mayo regimen or the simplified de Gramont regimen  , were studied for lactose tolerance by using an oral  lactose  absorption test , a symptom question naire , treatment-related toxicity , and Subjective Global Assessment of Nutritional Status question naire before , during , and 2 and 6 months after  chemotherapy for colorectal cancer . RESULTS The frequency of hypolactasia increased from 24 % before treatment to 35 % during treatment ( P < 0.0001 ) . Therapy-related hypolactasia was reversible on discontinuation of chemotherapy . Symptoms compatible with lactose intolerance occurred in 94 % of patients with an abnormal lactose absorption test result during chemotherapy . The frequency of hypolactasia increased during chemotherapy in both treatment groups , but was detected more commonly in those for whom therapy included continuous 5-FU infusions ( the de Gramont regimen ; 45 % vs. 25 % ; P = 0.006 ) . The presence of hypolactasia during chemotherapy was associated with flatulence , diarrhea , and poor nutritional status . CONCLUSIONS Reversible chemotherapy-related hypolactasia and lactose intolerance are not infrequent in patients treated with 5-FU-based adjuvant chemotherapy for colorectal cancer . Avoidance of lactose during chemotherapy may improve treatment tolerability in these patients Background Radiation-induced diarrhea is frequently observed during pelvic radiotherapy . This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients . Methods Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin  were r and omly assigned to a study drug or placebo , in a double-blind study . Diarrhea was grade d weekly according the Common Toxicity Criteria ( CTC ) system . Stool consistency and white and red blood cell count in stool were also assessed . The primary endpoint was to reduce the incidence of diarrhea , defined by a CTC grade 2 or more , and the need for anti-diarrheal medication . Results A total of 63 patients were enrolled .  Grade 2 -3 diarrhea was observed in 45 % of the placebo group ( n = 31 ) and 9 % of the study drug group ( n = 32 ) ( p = 0.002 ) . Anti-diarrheal medication use was significantly reduced in the placebo group ( p = 0.03 ) . The patients in the study drug group had a significantly improved stool consistency ( p < 0.001 ) . Conclusions Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency The clinical efficacy of LC9018 , a biological response modifier prepared from heat‐killed Lactobacillus casei YIT9018 , used in combination with radiation was studied in a r and omized controlled trial on 61 patients with carcinoma of the uterine cervix of Stage IIB or III . The combination therapy with LC9018 demonstrated a significant effect on tumor reduction , compared with radiation therapy alone , at the cumulative doses of 15‐Gy and 30‐Gy external irradiation ( P < 0.05 ) . Histologic study confirmed that LC9018 also enhanced the therapeutic effect of the irradiation . Moreover , LC9018 seemed to be useful in protecting the patients from leukopenia during radiotherapy . This study suggests that LC9018 , when used in combination with radiotherapy , will be an effective adjuvant immunotherapeutic agent . More studies in a large series of patients will , however , be needed to establish its long‐term efficacy , safety , and effects on both prognosis and enhancing radiotherapy The aim of the present study was to investigate the effect of Bifidobacterium animalis subsp . lactis , BB-12 ® , on two primary end points – defecation frequency and gastrointestinal ( GI ) well-being – in healthy adults with low defecation frequency and abdominal discomfort . A total of 1248 subjects were included in a r and omised , double-blind , placebo-controlled trial . After a 2-week run-in period , subjects were r and omised to 1 or 10 billion colony-forming units/d of the probiotic strain BB-12 ® or a matching placebo capsule once daily for 4 weeks . Subjects completed a diary on bowel habits , relief of abdominal discomfort and symptoms . GI well-being , defined as global relief of abdominal discomfort , did not show significant differences . The OR for having a defecation frequency above baseline for ≥50 % of the time was 1·31 ( 95 % CI 0·98 , 1·75 ) , P=0·071 , for probiotic treatment overall . Tightening the criteria for being a responder to an increase of ≥1 d/week for ≥50 % of the time result ed in an OR of 1·55 ( 95 % CI 1·22 , 1·96 ) , P=0·0003 , for treatment overall . A treatment effect on average defecation frequency was found ( P=0·0065 ) , with the frequency being significantly higher compared with placebo at all weeks for probiotic treatment overall ( all P<0·05 ) . Effects on defecation frequency were similar for the two doses tested , suggesting that a ceiling effect was reached with the one billion dose . Overall , 4 weeks ’ supplementation with the probiotic strain BB-12 ® result ed in a clinical ly relevant benefit on defecation frequency . The results suggest that consumption of BB-12 ® improves the GI health of individuals whose symptoms are not sufficiently severe to consult a doctor ( IS RCT N18128385 ) OBJECTIVE Nosocomial diarrhea is a major problem in pediatric hospitals worldwide . We evaluated the efficacy of orally administered Lactobacillus GG ( LGG ) in the prevention of this disease in young children . STUDY DESIGN Eighty-one children aged 1 to 36 months who were hospitalized for reasons other than diarrhea were enrolled in a double-blind trial and r and omly assigned at admission to receive LGG ( n = 45 ) at a dose of 6 x 10(9 ) colony-forming units or a comparable placebo ( n = 36 ) twice daily orally for the duration of their hospital stay . RESULTS LGG reduced the risk of nosocomial diarrhea ( > or =3 loose or watery stools/24 h ) in comparison with placebo ( 6.7 % vs 33.3 % ; relative risk : 0.2 ; [ 95 % CI : 0.06 - 0.6 ] ; number needed to treat : 4 [ 95 % CI : 2 - 10 ] ) . The prevalence of rotavirus infection was similar in LGG and placebo groups ( 20 % vs 27.8 % , respectively ; relative risk : 0.72 ; 95 % CI : 0.33 - 1.56 ) . However , the use of LGG compared with placebo significantly reduced the risk of rotavirus gastroenteritis ( 1/45 [ 2.2 % ] vs 6/36 [ 16.7 % ] , respectively ; relative risk : 0.13 ; 95 % CI : 0.02 - 0.79 ; number needed to treat : 7 ; 95 % CI : 3 - 40 ) . CONCLUSIONS Prophylactic use of LGG significantly reduced the risk of nosocomial diarrhea in infants , particularly nosocomial rotavirus gastroenteritis BACKGROUND Zonulin is a newly discovered protein that has an important role in the regulation of intestinal permeability . Our previous study showed that probiotics can decrease the rate of infectious complications in patients undergoing colectomy for colorectal cancer . OBJECTIVE The objective was to determine the effects of the perioperative administration of probiotics on serum zonulin concentrations and the subsequent effect on postoperative infectious complications in patients undergoing colorectal surgery . DESIGN A total of 150 patients with colorectal carcinoma were r and omly assigned to the control group ( n = 75 ) , which received placebo , or the probiotics group ( n = 75 ) . Both the probiotics and placebo were given orally for 6 d preoperatively and 10 d postoperatively . Outcomes were measured by assessing bacterial translocation , postoperative intestinal permeability , serum zonulin concentrations , duration of postoperative pyrexia , and cumulative duration of antibiotic therapy . The postoperative infection rate , the positive rate of blood microbial DNA , and the incidence of postoperative infectious complications-including septicemia , central line infection , pneumonia , urinary tract infection , and diarrhea-were also assessed . RESULTS The infection rate was lower in the probiotics group than in the control group ( P < 0.05 ) . Probiotics decreased the serum zonulin concentration ( P < 0.001 ) , duration of postoperative pyrexia , duration of antibiotic therapy , and rate of postoperative infectious complications ( all P < 0.05 ) . The p38 mitogen-activated protein kinase signaling pathway was inhibited by probiotics . CONCLUSIONS Perioperative probiotic treatment can reduce the rate of postoperative septicemia and is associated with reduced serum zonulin concentrations in patients undergoing colectomy . We propose a clinical regulatory model that might explain this association . This trial was registered at http://www.chictr.org/en/ as ChiCTR-TRC-00000423 Cancer treatment regimens that include radiation therapy ( RT ) to the abdominal region for cervical , ovarian , prostate , sigmoid , or colorectal cancer potentially disturb the colonization resistance of the indigenous gut flora , causing RT-induced diarrhea , enteritis , and colitis in more than 80 % of patients with cancer . One approach for the prevention of RT-induced diarrhea is the use of probiotics . R and omized clinical trials have demonstrated efficacy of probiotic preparations VSL # 3 and Lactobacillus casei DN-114 001 in decreasing the incidence and grade of RT-induced diarrhea . Oncology nurses and advanced practice clinicians are in a position to interpret research findings related to RT-induced diarrhea , enteritis , and colitis and to apply evidence -based practice principles in patients with cancer receiving RT to promote positive outcomes PURPOSE To determine whether a probiotic drink containing Lactobacillus casei DN-114 001 reduces the incidence of radiation-induced diarrhea in patients with gynecologic cancer . METHODS AND MATERIAL S Patients who were undergoing pelvic radiotherapy ( 45 - 50 Gy , conventional fractionation ) for either cervical carcinoma ( radiotherapy and weekly cisplatin ) or endometrial adenocarcinoma ( postoperative radiotherapy ) were r and omly assigned to a probiotic drink or placebo , in a double-blind fashion . The probiotic drink consisted of liquid yogurt containing L. casei DN-114 001 at 10(8 ) CFU/g . The patients recorded the daily the number of bowel movements and scored the stool consistency using the Bristol scale . Diarrhea was grade d weekly according the Common Toxicity Criteria system . The primary endpoint was to reduce the incidence of diarrhea , defined by a Common Toxicity Criteria Grade of 2 or greater or the need for loperamide . RESULTS A total of 85 patients were enrolled .  Grade 2 or greater diarrhea and /or the use of loperamide was observed in 24 of 41 patients in the placebo group and 30 of 44 in the probiotic group ( p = 0.568 ) . No differences were found in the median time to the presentation of the primary endpoint . Probiotic intervention had a significant effect on stool consistency ( p = 0.04 ) . The median time for patients to present with Bristol scale stools of Type 6 or greater was 14 days for patients receiving the probiotic drink vs. 10 days for those receiving placebo . CONCLUSION Nutritional intervention with the probiotic drink containing L. casei DN-114 001 does not reduce the incidence of radiation-induced diarrhea as defined by a Common Toxicity Criteria Grade 2 or greater . However , it had a significant effect on stool consistency as measured by the Bristol scale Background / Objectives : The pathogenesis of enteritis after abdominal radiotherapy ( RT ) is unknown , although changes in fecal microbiota may be involved . Prebiotics stimulate the proliferation of Lactobacillus spp and Bifidobacterium spp , and this may have positive effects on the intestinal mucosa during abdominal RT.Subjects/ Methods : We performed a r and omized , double-blind , placebo-controlled trial involving patients with gynecological cancer who received abdominal RT after surgery .  Patients were r and omized to receive prebiotics or placebo . The prebiotic group received a mixture of fiber ( 50 inulin and 50 % fructo-oligosaccharide ) , and the placebo group received 6 g of maltodextrin twice daily from 1 week before to 3 weeks after RT . The number of bowel movements and stool consistency was recorded daily . Diarrhea was evaluated according to the Common Toxicity Criteria of the National Cancer Institute . Stool consistency was assessed using the 7-point Bristol scale . Patients ’ quality -of-life was evaluated at baseline and at completion of RT using the EORTC-QLQ-C30 ( European Organization for Research and Treatment of Cancer quality -of-life Question naire C30 ) test . Results : Thirty-eight women with a mean age of 60.3±11.8 years participated in the study . Both groups ( prebiotic ( n=20 ) and placebo ( n=18 ) ) were comparable in their baseline characteristics . The number of bowel movements per month increased in both groups during RT . The number of bowel movements per day increased in both groups . The number of days with watery stool ( Bristol score 7 ) was lower in the prebiotic group ( 3.3±4.4 to 2.2±1.6 ) than in the placebo group ( P=0.08 ) . With respect to quality -of-life , the symptoms with the highest score in the placebo group were insomnia at baseline and diarrhea toward the end of the treatment . In the prebiotic group , insomnia was the symptom with the highest score at both assessment s , although the differences were not statistically significant . Conclusions : Prebiotics can improve the consistency of stools in gynecologic cancer patients on RT . This finding could have important implication s in the quality -of-life of these patients during treatment Purpose . To assess the acute toxicity profile of whole pelvis IMRT ( WP-IMRT ) for localized prostate cancer . Material s. Eighty seven patients treated with definitive WP-IMRT at UTMB from May 2002 to November 2006 were retrospectively review ed . Treatment consisted of two sequential phases , WP-IMRT to 54 Gy at 1.8 Gy per fraction to the pelvic nodes and seminal vesicles and 60 Gy at 2 Gy to the prostate , and a separate external beam boost , 3DCRT or IMRT , to bring the dose to the prostate to 76 Gy . Acute toxicity was prospect ively scored weekly during treatment and at 3 month follow-up according to CTC v2.0 for 10 genitourinary ( GU ) and gastrointestinal ( GI ) domains . The proportion of patients experiencing a given level of peak acute toxicity at a given point is reported . Results . Treatment was feasible with delivered doses to PTVs not significantly lower than planned ones and with only two patients experiencing treatment gaps longer than 5 days . About 2/3 and 1/10 of the patients experienced peak grade 2 and grade 3 reactions at least once during RT , respectively . Frequency/urgency ( Grade 2 + : 37.9 % ) and diarrhea ( 36.7 % ) were the most prevalent symptoms followed by proctitis ( 21.8 % ) and dysuria ( 16.1 % ) . GI reactions were generally shorter lasting compared to GU ones which accumulated progressively during treatment . At 3 months , almost half of the patients were asymptomatic and most of observed reactions ( 89.2 % ) were mild , with GI ones more likely to be fully resolved ( 92.5 % ) than GU ones ( 68.7 % , χ2 , p=0.001 ) . Conclusion . Our approach is dosimetrically and clinical ly feasible with intense , but transient , acute toxicity OBJECTIVE --To determine the safety and efficacy of a new combination treatment for patients with Clostridium difficile-associated disease ( CDD ) . The treatment combines the yeast Saccharomyces boulardii with an antibiotic ( vancomycin hydrochloride or metronidazole ) . DESIGN --A double-blind , r and omized , placebo-controlled , parallel-group intervention study in patients with active CDD . Patients received st and ard antibiotics and S boulardii or placebo for 4 weeks , and were followed up for an additional 4 weeks after therapy . Effectiveness was determined by comparing the recurrence of CDD in the two groups using multivariate analysis to control for other risk factors for CDD . SETTING --National referral study of ambulatory or hospitalized patients from three main study coordinating centers . PATIENTS --A total of 124 eligible consenting adult patients , including 64 who were enrolled with an initial episode of CDD , and 60 who had a history of at least one prior CDD episode . Patients who were immunosuppressed due to acquired immunodeficiency syndrome or cancer chemotherapy within 3 months were not eligible . INTERVENTION -- Treatment with oral S boulardii ( 1 g/d for 4 weeks ) or placebo in combination with a st and ard antibiotic . MAIN OUTCOME MEASURE -- Recurrence of active CDD . RESULTS --A history of CDD episodes dramatically increased the likelihood of further recurrences . Multivariate analysis revealed that patients treated with S boulardii and st and ard antibiotics had a significantly lower relative risk ( RR ) of CDD recurrence ( RR , 0.43 ; 95 % confidence interval , 0.20 to 0.97 ) compared with placebo and st and ard antibiotics . The efficacy of S boulardii was significant ( recurrence rate 34.6 % , compared with 64.7 % on placebo ; P = .04 ) in patients with recurrent CDD , but not in patients with initial CDD ( recurrence rate 19.3 % compared with 24.2 % on placebo ; P = .86 ) . There were no serious adverse reactions associated with S boulardii . CONCLUSIONS --The combination of st and ard antibiotics and S boulardii was shown to be an effective and safe therapy for these patients with recurrent CDD ; no benefit of S boulardii was demonstrated for those with an initial episode of CDD Background and aims Gastrointestinal toxicity is frequently observed during radiotherapy for malignancies in the abdomen and pelvis . This study was performed to determine the efficacy and tolerability of Lactobacillus rhamnosus ( Antibiophilus ® ) in comparison to placebo in a double-blind trial design . Its aim was to determine any clinical ly relevant difference between Antibiophilus ® and placebo in terms of efficacy in patients suffering from mild to moderate diarrhoea induced by radiation therapy . Methods The study was performed in two radiotherapy units in Hungary ; the results are based on the data for 206 recruited patients . Results Based on statistical analysis , Antibiophilus ® patients showed superiority with respect to the number of bowel movements ( P < 0.10 ) and faeces consistency ratings by the investigators ( P < 0.05 ) at the study end . Statistical analysis of the patients ’ self-ratings with regard to diarrhoea grade and faeces consistency showed a statistically highly significant treatment-by-time interaction ( P < 0.001 ) which was supported by the evidence of tendencies or P values below the nominal 5 % level in the second half of this study . Conclusions Overall , there was a highly favourable benefit/risk ratio in favour of Antibiophilus ® Twenty-four female patients suffering from gynaecological malignancies and scheduled for internal and external irradiation of the pelvic area ( pelvic dose 5000 cGy ) were selected for a study on prevention of intestinal side-effects by live Lactobacillus acidophilus cultures . The patients were r and omised into two groups . Both groups received dietary counselling recommending a low-fat and low-residue diet during radiotherapy . The control group received dietary counselling only . The test group received 150 ml of a fermented milk test product supplying them with at least 2 X 10(9 ) live Lactobacillus acidophilus bacteria daily and 6.5 % lactulose as substrate for the bacteria . The results indicated that the test product appeared to prevent radiotherapy-associated diarrhoea . However , flatulence was increased probably due to lactulose ingestion in the test group 5-Fluorouracil (5-FU)-based chemotherapy is frequently associated with diarrhoea . We compared two 5-FU-based regimens and the effect of Lactobacillus and fibre supplementation on treatment tolerability . Patients diagnosed with colorectal cancer ( n=150 ) were r and omly allocated to receive monthly 5-FU and leucovorin bolus injections ( the Mayo regimen ) or a bimonthly 5-FU bolus plus continuous infusion ( the simplified de Gramont regimen ) for 24 weeks as postoperative adjuvant therapy . On the basis of r and om allocation , the study participants did or did not receive Lactobacillus rhamnosus GG supplementation ( 1–2 × 1010 per day ) and fibre ( 11 g guar gum per day ) during chemotherapy . Patients who received Lactobacillus had less grade 3 or 4 diarrhoea ( 22 vs 37 % , P=0.027 ) , reported less abdominal discomfort , needed less hospital care and had fewer chemotherapy dose reductions due to bowel toxicity . No Lactobacillus-related toxicity was detected . Guar gum supplementation had no influence on chemotherapy tolerability . The simplified de Gramont regimen was associated with fewer grade 3 or 4 adverse effects than the Mayo regimen ( 45 vs 89 % ) , and with less diarrhoea . We conclude that Lactobacillus GG supplementation is well tolerated and may reduce the frequency of severe diarrhoea and abdominal discomfort related to 5-FU-based chemotherapy
BACKGROUND Treament-related diarrhoea is one of the most common and troublesome adverse effects related to chemotherapy or radiotherapy in people with cancer .
Its reported incidence has been as high as 50 % to 80 % .
Severe treatment-related diarrhoea can lead to fluid and electrolyte losses and nutritional deficiencies and could adversely affect quality of life ( QoL ) .
It is also associated with increased risk of infection in people with neutropenia due to anticancer therapy and often leads to treatment delays , dose reductions , or treatment discontinuation .
Probiotics may be effective in preventing or treating chemotherapy- or radiotherapy-induced diarrhoea .
OBJECTIVES To evaluate the clinical effectiveness and side effects of probiotics used alone or combined with other agents for prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer .