Saccharomyces boulardiiSpeeds Resolution of Rotavirus Diarrhea (2012)

Source: Correa NB, Penna FJ, Lima FM, et al. Treatment of acute diarrhea with Saccharomyces boulardii in infants. J Pediatr Gastroenterol Nutr. 2011; 53(5): 497– 501; doi: 10.1097/MPG.0b013e31822b7ab0Researchers from Brazil conducted a randomized, double-blind, placebo- controlled trial to evaluate the effectiveness of oral Saccharomyces boulardii in shortening diarrhea duration in infants. The researchers enrolled infants and toddlers aged 6 to 48 months admitted to two Brazilian hospitals with less than 72 hours of acute diarrhea. Patients were excluded for exclusive breastfeeding, antibiotics or diarrhea in the two weeks prior, hematochezia, severe malnutrition, inability to tolerate oral nutrition, and other underlying diseases. Patients were randomly assigned to receive either a commercially available capsule containing 200 mg of S boulardii or a placebo capsule containing 200 mg of the inactive components of the probiotic; both patients and caregivers were blinded as to capsule contents. Patients and controls received one capsule by mouth twice per day for five days. The measured endpoint was either less than three stools per day or an improved stool consistency for at least 24 hours. The patients otherwise received only fluid and nutrition as therapy, and if there was no improvement within four days they were taken out of the study for further treatment. The authors also tested for rotavirus in a substantial number of patients and performed a subgroup analysis for the rotavirus-positive patients (rotavirus was detected in ~57% of patients).Researchers initially enrolled 186 children, of whom five withdrew and five were removed from the study due to need for antibiotics. Ninety probiotic patients and 86 controls completed the study period, and there were no adverse events requiring discontinuation in either group. There were no differences in age, sex, growth parameters, stool characteristics before enrollment, or frequency of rotavirus between groups.Among those whose treatment was initiated within 72 hours of onset, there was a statistically significant (P<.01) reduction in the percentage of patients persisting with diarrhea at three days in the probiotic group (32.2%) versus the placebo group (59.2%). In subgroup analysis, the protective effect reached statistical significance only in patients infected with rotavirus. The authors conclude that their data support the use of S boulardii as an adjunctive therapy in acute diarrhea in infants and toddlers.Drs Makkuda and LeLeiko have disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.This study adds to a growing body of literature regarding the importance of the intestinal microbiota and the possible role of probiotics in gastrointestinal disease. Several prior studies looked at the use of probiotics in acute diarrhea, but differences in methodology and probiotics used have made the practical interpretation and application very difficult to discern.1,2 While the data presented here are interesting, there are several issues that make it hard to generalize and to apply these findings. The authors specifically chose patients who were ill enough to be hospitalized, and noted a statistically significant therapeutic effect in patients infected with rotavirus, when probiotics were started within 72 hours of the onset of the diarrhea. From the point of view of North American pediatricians, the latter would seem to be a particularly problematic finding as many patients who are hospitalized have often been ill for over 72 hours and the introduction of effective rotavirus vaccines has markedly decreased the rate of rotavirus infection and hospitalizations for acute gastroenteritis.3Thus, although probiotics are frequently used empirically in this setting, more systematic investigation of their possible benefits in acute diarrhea, especially in non-rotavirus-induced diarrhea, is needed. It is increasingly clear that the intestinal microbiome plays an important role in health and in disease. It is also clear that the appropriate application of our knowledge of the microbiome and how to alter it remains to be determined. Studies such as this continue to encourage us to pay close attention to this developing field, but at this time they lack the clarity to alter our practice of medicine in the sick child.Probiotics continue to occupy our minds and our pages. Amongst the gastrointestinal ills for which primarily bacterial probiotic efficacy has been documented are antibiotic-associated diarrhea, travelers’ diarrhea, acute viral gastroenteritis, and chronic constipation (see AAP Grand Rounds, June 2001;5[6]:584; June 2004;11[6]:655; Dec 2010;24[6]:68;6 June 2010;23[6]:677). This study utilized a probiotic yeast; other studies employed Bifidobacterium, lactobacillus GG, and L reuteri. We look forward to the 2012 Red Book, which promises to discuss the role of probiotics and, we hope, provide guidance in their selection.