Effects of Multi-Strain Probiotics on Gut Microbiome in Children and Teens with Inflammatory Bowel Disease A Randomized 11 Controlled Cross-Over Trial with Blinded Outcome Assessment

What this Trial Is About

Researchers are studying children and adolescents aged 5 to 18 years with inflammatory bowel disease to understand how multi-strain probiotics might affect their intestinal microbiome and metabolic profiles. This randomized, crossover trial aims to compare periods of probiotic supplementation with observation phases to explore these effects. Participants receive either an 8-week course of multi-strain probiotics followed by a 6-week washout and an 8-week observation or start with an 8-week observation, then a 6-week washout, and finish with 8 weeks of probiotic supplementation. The study includes a blinded outcome assessment and random allocation to treatment sequences. During the 22-week study period, participants undergo assessments of specific bacteria abundance, microbiome analyses, clinical responses, and laboratory evaluations both locally and systemically. These measures help researchers understand how the probiotics influence gut health and disease activity over time. The study is sponsored by Insel Gruppe AG, University Hospital Bern.

Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease