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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Inflamatory Bowel Disease
• Intervention / Treatment: Other: Observation; Other: Probiotic Formula

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christiane Sokollik, Prof; Phone Number: +41 31 632 21 11; Email: christiane.sokollik@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation	Other: Probiotic Formula; multi-strain probiotics
Other: Observation; 8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation	Other: Observation; Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abundance of specific bacteria	operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3	22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiome analysis	diversity (Shannon Index) and composition (beta diversity metrics (Bray-Curtis dissimilarity)) at T0,T1,T2,T3	22 weeks
clinical response	clinical activity scores: ΔPUCAI for UC, ΔPCDAI for CD at T0,T1,T2,T3	22 weeks
laboratory response - local	fecal calprotection at T0,T1,T2,T3	22 weeks
laboratory response - systemic	Composite assessment of C-reactive protein, thrombocytes and ESR at T0,T1,T2,T3	22 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life in 9 -17 years of age	Impact III score at T0,T1,T2,T3	22 weeks

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of Bern; Clinical Trials Unit University of Bern
• Investigators: Principal Investigator: Christiane Sokollik, Prof, Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; microbiome; inflammatory bowel disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 6110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported, after deidentification
• IPD Sharing Time Frame: Immediately following publication, ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committe identified for this purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No