Fecal microbiome signature of multi-strain probiotic supplementation in children and adolescents with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines how a probiotic formula affects the intestinal microbiome and metabolic profiles in pediatric patients with inflammatory bowel disease. Participants are 5 to 18 years old and will receive probiotic therapy with observational monitoring. The trial uses predefined inclusion and exclusion criteria to select suitable candidates and will compare microbiome changes during intervention, with safety and feasibility endpoints in a real-world clinical setting. Data from Inselspital Bern and affiliated centers will inform potential microbiome-driven approaches to disease management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent
* Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)
* General good health
* Ability to understand and follow study procedures and understand informed consent
* Age 5 -18 years
* No probiotic therapy 4 weeks before entering into the study.

Exclusion Criteria:

* Participation in other clinical studies interfering with study procedures.
* Inability or contraindications to undergo the investigated intervention
* Severe or acute flare of disease (for UC PUCAI score ≥35, for CD wPCDAI \>40)
* Treatment escalation within last 4 weeks for uncontrolled disease.
* Antibiotic or probiotic therapy within the last 4 weeks.

Where it's running

• Inselspital, Universitätsspital Bern Kinderklinik
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Christiane Sokollik, Prof — Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
• Study coordinator: Christiane Sokollik, Prof
• Email: christiane.sokollik@insel.ch
• Phone: +41 31 632 21 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.