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

NCT07533890 | Recruiting DMC

• 1 other identifier: 6110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflamatory Bowel Disease

Keywords

microbiome; inflammatory bowel disease; probiotics

Outcome Measures

Primary Outcomes (1)

• abundance of specific bacteria

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

  22 weeks

Secondary Outcomes (4)

• microbiome analysis

  22 weeks

• clinical response

  22 weeks

• laboratory response - local

  22 weeks

• laboratory response - systemic

  22 weeks

Other Outcomes (1)

• quality of life in 9 -17 years of age

  22 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation

Other: Probiotic Formula

Observation

OTHER

8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation

Other: Observation

Interventions

Probiotic Formula OTHER

multi-strain probiotics

Probiotic

Observation OTHER

Observation

Observation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Clinical Trials Unit University of Bern: collaborator
• University of Bern: collaborator

Study Sites (1)

Inselspital, Universitätsspital Bern Kinderklinik

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Christiane Sokollik, Prof

  Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Sokollik, Prof

CONTACT

+41 31 632 21 11; christiane.sokollik@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication, ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committe identified for this purpose

Locations

CH (1)