The prophylactic use of probiotics in the prevention of radiation therapy-induced diarrhea. A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation. Effects of probiotic Lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: results from multicenter, randomized, placebo-controlled nutritional trial. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients Prevention of irinotecan induced diarrhea by probiotics: A randomized double blind, placebo controlled pilot study. Are probiotics safe for use during pregnancy and lactation? Multicenter, Phase III Trial Comparing Selenium Supplementation With Observation in Gynecologic Radiation Oncology
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 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 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 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 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 QUESTION There has been a great deal of discussion in both the medical and lay literature about the use of probiotics to improve general health . Subsequently , pregnant women have been asking me if probiotics used for treating conditions such as bacterial vaginosis and diarrhea are safe to use during pregnancy and lactation . ANSWER Current data suggest that probiotic supplementation is rarely systemically absorbed when used by healthy individuals . One meta- analysis and several r and omized controlled trials conducted with women during the third trimester of pregnancy did not report an increase in adverse fetal outcomes . There have been no published studies addressing Saccharomyces species use in pregnancy . Probiotics are unlikely to be transferred into breast milk Purpose . In 2010 , we reported that selenium ( Se ) supplementation during radiation therapy ( RT ) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients , and reduced the number of episodes and severity of RT-induced diarrhea . In the current study , we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients . Patients and Methods . Former patients were identified and question ed with respect to their health and well-being . Results . A total of 81 patients were r and omized in the initial supplementation study , 39 of whom received Se ( selenium group , SeG )  and 42 of whom served as controls ( control group , CG ) . When former patients were reidentified after a median follow-up of 70 months ( range = 0 - 136 ) , the actuarial 10-year disease-free survival rate in the SeG was 80.1 % compared to 83.2 % in the CG ( P = .65 ) , and the actuarial 10-year overall survival rate of patients in the SeG was 55.3 % compared to 42.7 % in the CG ( P = .09 ) . Conclusions . Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients ’ long-term survival . In view of its positive effects on RT-induced diarrhea , we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy
Probiotic supplementation showed beneficial effect in the prevention and treatment of radiation-induced diarrhea in experimental animal studies .
BACKGROUND AND AIMS Probiotic supplementation seems to provide beneficial effects in the prevention and treatment of  radiation-induced diarrhea .
We performed a systematic review and meta- analysis to estimate the efficacy of probiotic supplementation for prevention and treatment of  radiation-induced diarrhea .