Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease
Not applicable · Testing Probiotic Formula and Observation · 1 site · Insel Gruppe AG, University Hospital Bern
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Probiotic Formula and Observation. Condition(s) listed: Inflamatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 5 to 18
- Any sex
Some of the main requirements, copied from the record:
- Signed informed consent
- Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)
- General good health
Plus 3 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-05-01.
- Main results expected around 2028-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Switzerland.
Main thing being measured
- abundance of specific bacteria (22 weeks)
In the researchers’ words
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflamatory Bowel Disease |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Collaborators | Clinical Trials Unit University of Bern; University of Bern |
| Enrollment | 40 (estimated) |
| Start date | 2026-05-01 |
| Primary completion (est.) | 2028-12 |
| First posted | 2026-04-16 |
| Last updated | 2026-06-30 |
| Official title | Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease - an Explanatory 1:1 Randomized Controlled Cross-Over Proof-of-Concept Trial With Blinded Outcome Assessment |
| ClinicalTrials.gov ID | NCT07533890 |
Interventions
- Probiotic Formula (Other)
multi-strain probiotics - Observation (Other)
Observation
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Inselspital, Universitätsspital Bern Kinderklinik | Bern | Switzerland | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.