Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic Formula, Observation.
- Who it may be relevant to
- Registry conditions: Inflamatory Bowel Disease. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
Interventions
- Other Probiotic Formula
multi-strain probiotics - Other Observation
Observation
Primary outcome measures
- abundance of specific bacteria [Time frame: 22 weeks]
Secondary outcome measures (4)
- microbiome analysis [Time frame: 22 weeks]
- clinical response [Time frame: 22 weeks]
- laboratory response - local [Time frame: 22 weeks]
- laboratory response - systemic [Time frame: 22 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- Inselspital, Universitätsspital Bern Kinderklinik — Bern
Identifiers
NCT: NCT07533890 · 6110