Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07533890

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

In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Inflamatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital, Universitätsspital Bern Kinderklinik

Bern, Switzerland

Location status: Recruiting

Location contact

Christiane Sokollik, PD Dr. med.

CONTACT

[email protected]

+41 31 632 21 11

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Formula

Other

multi-strain probiotics

observation

Other

Observation

Primary outcomes

  1. abundance of specific bacteria

    Time frame: 22 weeks

    operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3

Secondary outcomes

  1. microbiome analysis

    Time frame: 22 weeks

    diversity (Shannon Index) and composition (beta diversity metrics (Bray-Curtis dissimilarity)) at T0,T1,T2,T3

  2. clinical response

    Time frame: 22 weeks

    clinical activity scores: ΔPUCAI for UC, ΔPCDAI for CD at T0,T1,T2,T3

  3. laboratory response - local

    Time frame: 22 weeks

    fecal calprotection at T0,T1,T2,T3

  4. laboratory response - systemic

    Time frame: 22 weeks

    Composite assessment of C-reactive protein, thrombocytes and ESR at T0,T1,T2,T3

Other outcomes

  1. quality of life in 9 -17 years of age

    Time frame: 22 weeks

    Impact III score at T0,T1,T2,T3

Study contacts

Contact information is provided by the study sponsor or research team.

Christiane Sokollik, Prof

CONTACT

[email protected]

+41 31 632 21 11

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Clinical Trials Unit University of Bern
  • University of Bern

Registry information

Official study 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

Acronym: MicroSig

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.