A Comprehensive Review and Meta-analysis on the Treatment of Acute Gastroenteritis in Children with a Bacillus clausii Preparation (Enterogermina®).

Abstract

Several probiotics have become guideline-recommended treatments for acute gastroenteritis in children, but no recommendation was made for Bacillus clausii preparations on the basis of too limited data. As available B. clausii preparations differ in regard to strain composition and pharmaceutical quality, we focused on the most frequently investigated preparation that is available under the brand name Enterogermina^®, which includes a combination of the O/C, SIN, N/R, and T strains. We performed a systematic review and meta-analysis including several newer studies. We identified 11 randomized and three non-randomized controlled trials. A meta-analysis was performed for the three most often reported parameters in the randomized trials, i.e., duration of diarrhea, number of stools, and duration of hospital stay. Risk of bias was assessed using the Centre for Reviews and Dissemination criteria. Risk of bias of the randomized trials was classified as fair to good. The duration of diarrhea was reduced by 0.6 Hedge's g, the number of stools by 0.34 Hedge's g, and the duration of hospital stay by 0.27 Hedge's g (p < 0.05 for all three parameters). Several other parameters also appeared improved. Adverse events were absent or similarly present in the B. clausii and control groups. We conclude that the B. clausii preparation analyzed here is an effective and well-tolerated treatment of acute gastroenteritis in children. However, more high-quality randomized controlled trials are needed, particularly in comparison to other probiotics.