Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study

ConclusionNo significant differences in efficacy betweenB. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30 –40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less ps ychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups.EudraCT number2018-004519-31.
Source: Pediatric Drugs - Category: Pediatrics Source Type: research