A Comprehensive Review and Meta-Analysis on the Treatment of Acute Gastroenteritis in Children with a<em> Bacillus clausii </em>Preparation (Enterogermina®)

Background/Objectives: Several probiotics have become guideline recommended treatments for acute gastroenteritis in children but no recommendation was made for Bacillus clausii preparations based on too limited data. As available B. clausii preparations differ in regard of strain composition and pharmaceutical quality, we focused on the most frequently investigated preparation that is available under the brand name Enterogermina® that includes a combination of the O/C, SIN, N/R and T strains. Therefore, we have performed a systematic review and meta-analysis including several newer studies. Methods: 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 by the criteria of the Centre for Reviews and Dissemination. Results: Risk of bias of the randomized trials was classified as fair to good. The duration of diarrhea was reduced by 0.6 pooled standard deviations, the number of stools by 0.34 pooled standard deviations, and the hospital stay by 0.27 pooled standard deviations (p&amp;lt;0.05 for all three parameters). Several other parameters also appeared improved Adverse events were absent or similarly present in the B. clausii and the control group. 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.