Abstract
Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillushelveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.
Highlights
Demographic and clinical characteristics of the probiotic and placebo groups are summarized in Table 1; there were no meaningful differences in index visit clinical parameters
No differences were detected in the mean post-randomization modified Vesikari scale (MVS) scores between probiotic and placebo groups for any of the five categories of pathogens analyzed; Table 2 and Fig. 2
We found no indication that probiotic administration lessens the burden of disease, quantified by the MVS score, regardless of the etiologic pathogen group or specific viral etiologies
Summary
The primary objective was to determine if a 5-day probiotic treatment course administered to children with AGE resulted in pathogen-specific clinical benefits quantified using the validated and widely-used[38] MVS score[39,40]. Secondary objectives identified a priori included (1) assessing if probiotic administration resulted in a greater reduction in stool pathogen load compared with placebo; and determining the relationship between (2) correlating baseline (Day 0) stool pathogen load and baseline MVS score, and (3) Day 5 stool pathogen load and the follow-up MVS score. The MVS score quantifies severity over a broad range of symptoms and interventions among outpatients. This measurement tool was validated in two prospective cohort studies in similar patient populations[39,40] and has been employed in several clinical trials[14,15,41]. Baseline symptoms that occurred prior to the index ED visit were not included in the follow-up MVS score calculation
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