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 The politics of probiotics: probiotics, necrotizing enterocolitis and the ethics of neonatal research Efficacy of Clostridium butyricum preparation concomitantly with Helicobacter pylori eradication therapy in relation to changes in the intestinal microbiota. World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Probiotics Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines Probiotics and prebiotics in gastrointestinal disorders The effect of fermented yogurt on the prevention of diarrhea in a healthy adult population. Acidified Milk Formula Supplemented With Bifidobacterium lactis: Impact on Infant Diarrhea in Residential Care Settings Effect of Lactobacillus GG Supplementation on Antibiotic-Associated Gastrointestinal Side Effects during Helicobacter pylori Eradication Therapy: A Pilot Study Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial Effect of different probiotic preparations on anti-Helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation Prophylactic Lactobacillus GGReduces Antibiotic-Associated Diarrhea in Children With Respiratory Infections: A Randomized Study Effect of Micronutrient and Probiotic Fortified Yogurt on Immune-Function of Anti-Retroviral Therapy Naive HIV Patients Evaluation of a Diet Containing Probiotics and Zinc for the Treatment of Mild Diarrheal Illness in Children Younger Than One Year of Age The effect of probiotics on Helicobacter pylori eradication. Multicenter, phase 3 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 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 ) Antibiotic associated diarrhea due to human intestinal microbiota abnormalities is a side effect of H. pylori eradication therapy . We examined intestinal microbiota changes during H. pylori eradication therapy and the preventive effect of CBM588 as a probiotic agent . Nineteen patients with gastro-duodenal ulcer were r and omly divided into three groups : group A ( without probiotics ) , group B ( with regular doses of CBM588 ) and group C ( with double doses of CBM588 ) . The incidence of diarrhea and soft stools during H. pylori eradication therapy was 43 % in group A and 14 % in group B , while none of the patients in group C reported diarrhea or soft stools . Both bacterial counts and detection rates of bifidobacteria and /or obligate anaerobe were decreased by eradication therapy . However , bacterial counts of obligate anaerobes in group C were significantly higher than in group A ( P < 0.05 ) . Additionally , during eradication therapy C. difficile toxin A was detected in both group A and group B but not in group C. In conclusion , these results indicate that H. pylori eradication therapy induces antibiotic associated diarrhea due to abnormalities in intestinal microbiota and /or C. difficile . However , these side effects might be prevented by probiotics 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 Background Adequate nutrition is essential during pregnancy and lactation to provide sufficient energy and nutrients to meet the nutritional requirements of the mother , fetus and infant . The primary objective of this study was to assess the effect of a maternal nutritional supplement enriched with probiotics during pregnancy and early lactation on the incidence of  infant diarrhea . Methods Healthy , pregnant ( 24–28 weeks gestation ) women were r and omized 1:1:1 to receive either no supplement or two servings per day of an oral supplement ( 140 kcal/serving ) providing 7.9 g protein , multivitamin/minerals , and enriched or not with the probiotics Lactobacillus rhamnosus and Bifidobacterium lactis , from the third trimester of pregnancy until at least 2 months post-delivery . Incidence of infant diarrhea until 12 months post-delivery was analyzed by Poisson regression . The effect on maternal health , fetal growth , and infant growth and morbidity were also evaluated and analyzed by ANOVA . Results A total of 208 mother/infant pairs were included in the analysis . No significant difference in the incidence of infant diarrhea was observed between the three study groups . The mean maternal weight gains at delivery were similar among groups , despite an increase in caloric intake in the supplemented groups . No statistically significant differences between groups were observed in incidence of pregnancy-related or fetal adverse outcomes . Mean weight- , length- , BMI - and head circumference-for-age z-scores were below the WHO median value for all groups . Post-hoc analysis to compare the effect of the combined supplement groups versus the no supplement group on infant growth parameters showed , at 12 months , that the combined supplemented group had gained statistically significant more weight ( 8.97 vs. 8.61 kg , p = 0.001 ) and height ( 74.2 vs. 73.4 cm , p = 0.031 ) , and had a higher weight-for-age z-score ( − 0.62 vs. -0.88 , p = 0.045 ) than the no supplement group . Conclusions Maternal nutritional supplement with or without probiotics given during late pregnancy and early lactation was well tolerated and safe . Even though no difference in incidence of infant diarrhea was observed between the three groups , the analysis of the combined supplemented groups showed beneficial effects of maternal supplementation on infant weight and length gains at 12 months . Trial registration Clinical Trial.gov : NCT01073033 . Registered 17.02.2010 Purpose of review This review summarizes the clinical efficacy of probiotics and prebiotics in gastrointestinal disorders and examines the mechanisms of action related to their therapeutic effect . Recent findings The demonstration that immune and epithelial cells can discriminate between different microbial species has extended the known mechanism(s ) of action of probiotics beyond simple barrier and antimicrobial effects . It has also confirmed that probiotic bacteria modulate mucosal and systemic immune activity and epithelial function . The progressive unraveling of these mechanisms of action has led to new credence for the use of probiotics and prebiotics in clinical medicine . Level I evidence now exists for the therapeutic use of probiotics in infectious diarrhea in children , recurrent Clostridium difficile – induced infections and postoperative pouchitis . Level II evidence is emerging for the use of probiotics in other gastrointestinal infections , prevention of postoperative bacterial translocation , irritable bowel syndrome , and in both ulcerative colitis and Crohn disease . Nevertheless , one consistent feature has emerged over the past year : Not all probiotic bacteria have similar therapeutic effects . Future clinical trials will need to incorporate this fact into trial planning and design . Summary The use of probiotics and prebiotics as therapeutic agents for gastrointestinal disorders is rapidly moving into the “ mainstream . ” Mechanisms of action explain the therapeutic effects and r and omized ; controlled trials provide the necessary evidence for their incorporation into the therapeutic armamentarium BACKGROUND Probiotic dairy products are increasingly gaining popularity . Although the role of probiotic bacteria in the prevention and treatment of pediatric and antibiotic associated diarrhea is fairly well established , their role in the prevention of adult infectious diarrhea has not been well investigated . METHODS Five hundred forty-one , young male military recruits were enrolled and r and omly assigned to receive a yogurt containing Lactobacillus casei ( n = 275 ) or a nonprobiotic yogurt ( n = 266 ) . The incidence and duration of diarrhea were documented and stool sample s examined for bacteria and parasites . RESULTS Five hundred and two participants were eligible for final analysis , 254 receiving probiotic yogurt and 248 in the control group . Seventy-one participants ( 14.14 % ) experienced diarrhea during the study period . The incidence of diarrhea in the probiotic group and the control group was 12.2 % and 16.1 % , respectively ( P = .207 ) . The mean duration of diarrhea was 3 + /- 1.95 days in the probiotic group and 2.6 + /- 1.08 days in the control group ( P = .276 ) . CONCLUSION Our study demonstrated a nonsignificant trend for reduction of the incidence of diarrhea among healthy young adults consuming yogurt containing Lactobacillus casei . Further study is needed to evaluate the role of probiotics in adults Objectives Probiotics may be useful in preventing acute infectious diarrhea .  Bifidobacteria are particularly attractive as probiotics agent because they constitute the predominant colonic flora of breastfed infants and are thought to play a role in the decreased incidence of diarrhea in breastfed infants . Methods This was a multicenter , double-blind , controlled study to evaluate the efficacy of a milk formula supplemented with viable Bifidobacterium lactis strain Bb 12 ( BbF ) in the prevention of acute diarrhea in infants younger than 8 months living in residential nurseries or foster care centers . Results Ninety healthy children received either the BbF or a conventional formula ( CF ) daily . The mean duration of the stay in the residential center was similar ( 137 v 148 days ) . At enrollment , there were no differences between the two groups with respect to age ( 3.7 ± 2.1 months ) , gender , anthropometric data , history of allergy or gastrointestinal disease , frequency of breast-feeding in the neonatal period or timing of introduction of solid food . Altogether , 28.3 % of the BbF infants  had diarrhea during the study compared with 38.7 % of controls ( NS ) . There was a statistically insignificant trend for shorter episodes of diarrhea in the BbF group ( 5.1 ± 3.3 days v 7 ± 5.5 days , NS ) . The number of days with diarrhea was 1.15 ± 2.5 in the BbF group with a daily probability of diarrhea of 0.84 versus 2.3 ± 4.5 days and 1.55 , respectively , in the CF group ( P = 0.0002 and 0.0014 ) . Feeding infants with the BbF reduced their risk of getting diarrhea by a factor of 1.9 ( range , 1.33–2.6 ) . Analysis of the cumulative incidence of diarrheal episodes showed a trend that the first onset of diarrhea occurred later in the BbF group . Conclusion These results provide some evidence that viable Bifidobacterium lactis strain Bb 12 , added to an acidified infant formula , has some protective effect against acute diarrhea in healthy children Background : One-week triple therapy is currently regarded as the reference of anti-Helicobacter pylori treatment . However , antibiotic-associated gastrointestinal side effects are among the major pitfalls of such regimens . Probiotic supplementation may be regarded as a therapeutic tool to prevent or reduce these troublesome drug-related manifestations . Aim : To determine whether the addition of the probiotic Lactobacillus GG to an anti-H. pylori st and ard triple therapy could help to prevent or minimize the occurrence of gastrointestinal side effects . Methods : One hundred and twenty healthy asymptomatic subjects screened positive for H. pylori infection and deciding to receive eradication therapy were r and omized either to 1-week pantoprazole ( 40 mg b.i.d . ) , clarithromycin ( 500 mg b.i.d . ) , tinidazole ( 500 mg b.i.d . ) or to the same regimen supplemented with Lactobacillus GG for 14 days . Patients filled in vali date d question naires during follow-up to determine the type and severity of side effects and to judge overall tolerability . Results : Bloating , diarrhea and taste disturbances were the most frequent side effects during the eradication week and were significantly reduced in the Lactobacillus GG-supplemented group ( RR = 0.4 , CI 0.2–0.8 ; RR = 0.3 , CI 0.1–0.8 ; RR = 0.3 , CI 0.1–0.7 , respectively ) . The same pattern was observed throughout the follow-up period . Overall assessment of treatment tolerability showed a significant trend in favor of the Lactobacillus GG-supplemented group ( p = 0.03 ) . Conclusions : Lactobacillus GG supplementation beneficially affects H. pylori therapy-related side effects and overall treatment tolerance Background Probiotics are an upcoming group of nutraceuticals cl aim ing positive effects on athlete ’s gut health , redox biology and immunity but there is lack of evidence to support these statements . Methods We conducted a r and omized , double-blinded , placebo controlled trial to observe effects of probiotic supplementation on markers of intestinal barrier , oxidation and inflammation , at rest and after intense exercise . 23 trained men received multi-species probiotics ( 1010 CFU/day , Ecologic ® Performance or OMNi-BiOTiC ® POWER , n = 11 ) or placebo ( n = 12 ) for 14 weeks and performed an intense cycle ergometry over 90 minutes at baseline and after 14 weeks . Zonulin and α1-antitrypsin were measured from feces to estimate gut leakage at baseline and at the end of treatment . Venous blood was collected at baseline and after 14 weeks , before and immediately post exercise , to determine carbonyl proteins ( CP ) , malondialdehyde ( MDA ) , total oxidation status of lipids ( TOS ) , tumor necrosis factor-alpha ( TNF-α ) , and interleukin-6 ( IL-6 ) . Statistical analysis used multifactorial analysis of variance ( ANOVA ) . Level of significance was set at p < 0.05 , a trend at p < 0.1 . Results Zonulin decreased with supplementation from values slightly above normal into normal ranges ( < 30 ng/ml ) and was significantly lower after 14 weeks with probiotics compared to placebo ( p = 0.019 ) . We observed no influence on α1-antitrypsin ( p > 0.1 ) . CP increased significantly from pre to post exercise in both groups at baseline and in the placebo group after 14 weeks of treatment ( p = 0.006 ) . After 14 weeks , CP concentrations were tendentially lower with probiotics ( p = 0.061 ) . TOS was slightly increased above normal in both groups , at baseline and after 14 weeks of treatment . There was no effect of supplementation or exercise on TOS . At baseline , both groups showed considerably higher TNF-α concentrations than normal . After 14 weeks TNF-α was tendentially lower in the supplemented group ( p = 0.054 ) . IL-6 increased significantly from pre to post exercise in both groups ( p = 0.001 ) , but supplementation had no effect . MDA was not influenced , neither by supplementation nor by exercise . Conclusions The probiotic treatment decreased Zonulin in feces , a marker indicating enhanced gut permeability . Moreover , probiotic supplementation beneficially affected TNF-α and exercise induced protein oxidation . These results demonstrate promising benefits for probiotic use in trained men . Clinical trial registryhttp://www . clinical trials.gov , identifier : OBJECTIVES : Several studies show that probiotics may prevent side effects during therapy against Helicobacter pylori ( H. pylori ) . Other reports indicate competitive interaction between some probiotics and H. pylori . We compared efficacy of two different probiotics and one probiotic combination with placebo for preventing anti-H. pylori therapy-related side effects and for improving the eradication rate . METHODS : A total of 85 H. pylori positive , asymptomatic patients were r and omized in four groups to receive probiotic or placebo both during and for 7 days after a 1-wk triple therapy scheme ( rabeprazole 20 mg b.i.d . , clarithromycin 500 mg b.i.d . , and tinidazole 500 mg b.i.d . ) . Group I ( n = 21 ) received Lactobacillus GG ; group II ( n = 22 ) , Saccharomyces boulardii ; group III ( n = 21 ) , a combination of Lactobacillus spp . and biphidobacteria ; and group IV ( n = 21 ) , placebo . Subjects filled in weekly symptom question naires for 4 wk . Blinded investigators collected and analyzed data . H. pylori status was rechecked after 5–7 wk . RESULTS : Side effects occurred mainly during the eradication week . None of them caused therapy discontinuation . In all probiotic-supplemented groups , there was a significantly lower incidence of diarrhea and taste disturbance during the eradication week with respect to the placebo group . Overall assessment of tolerability was significantly better in the actively treated patients than in the placebo group . No differences in the incidence of side effects between the probiotic groups were observed . The H. pylori eradication rate was almost identical between the probiotic and placebo groups . CONCLUSIONS : All the probiotics used were superior to placebo for side effect prevention , but were not associated with better compliance with antibiotic therapy . The effect of probiotic supplementation on side effects during anti-H. pylori regimens seemed to be independent of the probiotic species used Background and Aim . The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated . Methods . A r and omized , double-blind , three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups ( F_1 , F_2 , and F_3 ) . Each group received a daily oral administration of probiotic mixtures ( for 60 days ) F_1 or F_2 or placebo F_3 , respectively . Fecal microbiological analyses were performed by  species-specific qPCR  to assess the different amount of probiotics . Results . The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period ( t60 ) and was maintained quite similar during the follow-up period ( t90 ) . Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3 , and the same level was maintained during the follow-up period . Conclusions . Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota . This clinical study is registered with the clinical study registration number IS RCT N15032219 Objectives . Antimicrobial treatment may disturb the colonization resistance of gastrointestinal microflora , which may induce clinical symptoms , most commonly diarrhea . The severity of antibiotic-associated diarrhea may range from a brief , self-limiting disease to devastating diarrhea with electrolyte disturbances , dehydration , crampy abdominal pain , pseudomembranous colitis , toxic megacolon , or even death . The incidence of diarrhea in children receiving a single antimicrobial treatment is unclear . In addition to more critical use of antimicrobials , adjunctive preventive measures to antibiotic-associated diarrhea are needed . The objective of this study was to evaluate the incidence of diarrhea after antimicrobial treatment in children with no history of antimicrobial use during the previous 3 months . Another aim of this study was to assess the preventive potential of Lactobacillus rhamnosus GG ( Lactobacillus GG ; American Type Culture Collection 53103 ) , a probiotic strain with a documented safety record and a therapeutic effect in viral gastroenteritis on antibiotic-associated diarrhea . Methods . Oral antimicrobial agents were prescribed for the treatment of acute respiratory infections at the clinics of the Health Care Center of the City of Tampere or Tampere University Hospital , Finl and , to 167 patients who were invited to participate in the study . Of the patients , 48 were lost to follow-up ; therefore , the final study population consisted of 119 children from 2 weeks to 12.8 years of age ( mean : 4.5 years ) . All study subjects met the inclusion criteria : they had not received any antimicrobial medication during the previous 3 months , they did not suffer from gastrointestinal disorders , and they did not need intravenous antimicrobial treatment . The patients were r and omized to receive placebo or 2 × 1010 colony-forming units of Lactobacillus GG in capsules given twice daily during the antimicrobial treatment . Lactobacillus GG and placebo capsules were indistinguishable in appearance and taste . The parents kept a daily symptom diary and recorded stool frequency and consistency at home for 3 months . Diarrhea was defined as at least three watery or loose stools per day for a minimum of 2 consecutive days . In the case of diarrhea , viral ( adenovirus , rotavirus , calicivirus and astrovirus ) and bacterial ( Salmonella , Shigella , Yersinia , Campylobacter , Clostridium difficile , Staphylococcus aureus , and yeasts ) analyses were studied in fecal sample s. The metabolic activity of the gut microflora was assessed by analysis of fecal urease , β-glucosidase , and β-glucuronidase activities . The primary outcome measure was diarrhea during the first 2 weeks after the beginning of the antimicrobial treatment , because this period most likely reflects the effects of antimicrobial use . Secondary outcome measures were the activities of fecal urease , β-glucuronidase , and β-glucosidase . Results . On the entire follow-up , 80 % of any gastrointestinal symptoms were reported during the first 2 weeks after the beginning of the antimicrobial treatment . The incidence of diarrhea was 5 % in the  Lactobacillus GG group and 16 % in the placebo group within 2 weeks of antimicrobial therapy ( χ2 = 3.82 ) . The treatment effect ( 95 % confidence interval ) of Lactobacillus GG was −11 % ( −21%–0 % ) . In diarrheal episodes , the viral and bacterial analyses were positive for Clostridium difficile in 2 cases and for Norwalk-like calicivirus in 3 cases . The age of the patients with diarrhea was between 3 months and 5 years in 75 % of cases in both groups .  The severity of diarrhea was comparable in the study groups , as evidence d by similar stool frequency ( mean : 5 per day ; range : 3–6 ) and the duration of diarrhea ( mean : 4 days ; range : 2–8 ) . The activities of fecal urease and β-glucuronidase , but not β-glucosidase , changed significantly after the beginning of the antimicrobial treatment in the Lactobacillus GG group and in the placebo group alike . The decrease in urease and β-glucuronidase activities was reversible in patients with no diarrhea , but in patients with diarrhea , the modifications in gut microflora were more profound and prolonged . The activities of the three enzymes were normalized within 3 weeks , evidence d by stable enzyme activities in sample s collected 3 weeks , 1 month , and 3 months after the beginning of the antimicrobial treatment , compared with those obtained before treatment . Discussion . In the present study , after a single antimicrobial treatment , the incidence of diarrhea was 16 % . The higher incidence of antibiotic-associated diarrhea in previous reports may be attributable to a recent antimicrobial therapy that disturbs intestinal flora and exposes to complications . Also , in the present study , changes in the metabolic activity of the intestinal flora were observed , evidence d by a transient decline in fecal enzyme activities . Different probiotic preparations , including lactobacilli , are recommended frequently to prevent antibiotic-associated diarrhea . Although probiotics have been shown to be efficient in the prevention and the treatment of viral gastroenteritis , their usefulness during antimicrobial therapy in children has not been eluci date d before . We observed that the administration of Lactobacillus GG to children receiving antimicrobial therapy for respiratory infection reduced the incidence of antibiotic-associated diarrhea to one third . The beneficial effect may be mediated by a number of functions of probiotics , ie , production of antimicrobial substances , local competition of adhesion receptors and nutrients , and stimulation of intestinal antigen specific and nonspecific immune responses . Conclusion . A probiotic strain , Lactobacillus GG , is effective in the prevention of diarrhea in children receiving antimicrobial treatment to respiratory infections Background : Micronutrient supplementation has been shown to reduce the progression of HIV but does not have an effect on the intestinal barrier or the intestinal microbiota of HIV patients . Studies have suggested that probiotics could potentially complement micronutrients in preserving the immune-function of HIV patients . Objective : Assess the impact of micronutrient supplemented probiotic yogurt on the immune function of HIV patients . Design : We performed a r and omized , double blind , controlled trial with CD4 count as primary outcome among HIV patients naïve to anti-retroviral treatment . Secondary outcomes included hematological parameters , incidence of diarrhea and clinical symptoms . A total of 112 HIV patients were r and omized to receive a micronutrient fortified yogurt with ( n = 55 ) or without additional probiotic Lactobacillus rhamnosus GR-1 ( n = 57 ) for four weeks . Results : An average decline in CD4 count of −70 cells/μL ( 95 % CI : −154 to −15 ) was observed in the micronutrient , probiotic group versus a decrease of −63 cells/μL ( 95 % CI : −157 to −30 ) in the micronutrient control group ( p = 0.9 ) . Additional probiotic supplementation was well tolerated and not associated with adverse events . No difference between groups was detected in incidence of diarrhea or clinical symptoms . An improvement of hemoglobin levels was observed for all subjects , based upon a mean difference from baseline of 1.4 g/L ( SD = 6 ) ( p = 0.02 ) . Conclusion : The addition of probiotics to a micronutrient fortified yogurt was well tolerated by HIV patients but was not associated with a further increase in CD4 count after one month Objectives : Supplementation of probiotics and supplementation of zinc during acute gastroenteritis in children have been shown to exert positive effects on diarrhea duration and severity . Our aim was to evaluate a new diet enriched with zinc and probiotic bacteria in the treatment of acute gastroenteritis in young children . Methods : In a double blind prospect i ve study , 65 children aged 6–12 months were r and omized to receive 6 × 109 colony forming units of Streptococcus thermophilus , Bifidobacterium lactis , Lactobacillus acidophilus ( 2 × 109 of each strain ) , 10 mg of zinc/day , and 0.3 grams of fructo-oligosaccharides in the supplemented group ( n = 33 ) or placebo ( n = 32 ) , given in a soy protein based rice cereal . For each child , age , sex , weight , degree of dehydration , the presence of fever or vomiting , stool frequency and consistency were recorded daily until diarrhea resolution . Results : Diarrhea resolution occurred after 1.43 ± 0.71 days in the supplemented group vs. 1.96 ± 1.24 in the control group ( p = 0.017 ) . In the subset of children who presented with vomiting , time to vomiting resolution was 0.27 ± 0.59 vs. 0.81 ± 0.91 days in the supplemented and control groups , respectively ( p = 0.06 ) . On day 3 , there was only 1 child with watery stools in the supplemented group versus 10 children in the control group ( p = 0.02 ) . Conclusions : In our series , the feeding of a cereal containing Streptococcus thermophilus , Bifidobacterium lactis , Lactobacillus acidophilus and zinc , reduced the severity and duration of acute gastroenteritis in young children . However , whether this combination is better than either the addition of probiotics or zinc alone is yet to be determined BACKGROUND / AIMS Conflicting results have been reported on the effect of a variety of probiotic strains on  Helicobacter pylori ( HP ) eradication . In this study , we evaluated the outcome of a probiotic strain composed of bacillus subtilis and Streptococcus faecium on HP eradication . METHODOLOGY We recruited 352 HP infected patients who were r and omized into a triple-plus-probiotics group or a triple-only group ; the participants received 1 week of PPI-based triple therapy with or without probiotics supplements . For the triple-plus-probiotics group , probiotics was continued for 8 weeks . All patients in the two groups were evaluated for 4 weeks after completion of therapy . RESULTS Using the intention to treat analysis , evaluation of the triple-plus-probiotics group showed a higher eradication rate than the triple-only group ( 83.5 % vs. 73.3 % , p=0.027 ) . Diarrhea and overall side effects were more common in the triple-only group ( p<0.05 ) . CONCLUSIONS Supplementation with probiotic strains , composed of Bacillus subtilis and Streptococcus faecium , were shown to improve drug compliance , reduce side effects and enhance the intention-to-treat eradication rate of HP PURPOSE We assessed whether adjuvant supplementation with selenium improves the selenium status and reduces side effects of patients treated by radiotherapy ( RT ) for cervical and uterine cancer . METHODS AND MATERIAL S Whole-blood selenium concentrations were measured in patients with cervical cancer ( n = 11 ) and uterine cancer ( n = 70 ) after surgical treatment , during RT , at the end of RT , and 6 weeks after RT . Patients with initial selenium concentrations of less than 84μg/L were r and omized before RT either to receive 500 μg of selenium ( in the form of sodium selenite [ selenase , biosyn Arzneimittel GmbH , Fellbach , Germany ] ) by mouth on the days of RT and 300 μg of selenium on the days without RT or to receive no supplement during RT . The primary endpoint of this multicenter Phase 3 study was to assess the efficiency of selenium supplementation during RT ; the secondary endpoint was to decrease radiation-induced diarrhea and other RT-dependent side effects . RESULTS A total of 81 patients were r and omized . We enrolled 39 in the selenium group ( SG ) and 42 in the control group ( CG ) . Selenium levels did not differ between the SG and CG upon study initiation but were significantly higher in the SG at the end of RT . The actuarial incidence of diarrhea of Grade 2 or higher according to Common Toxicity Criteria ( version 2 ) in the SG was 20.5 % compared with 44.5 % in the CG ( p = 0.04 ) . Other blood parameters , Eastern Cooperative Oncology Group performance status , and self-reported quality of life were not different between the groups . CONCLUSIONS Selenium supplementation during RT is effective in improving blood selenium status in selenium-deficient cervical and uterine cancer patients and reduces the number of episodes and severity of RT-induced diarrhea
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 .