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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07533890

Acronym

MicroSig

Enrollment

Registered

2026-04-16

Start date

2026-04-01

Completion date

2028-12-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflamatory Bowel Disease

Keywords

microbiome, inflammatory bowel disease, probiotics

Brief summary

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

Interventions

OTHERProbiotic Formula

multi-strain probiotics

OTHERObservation

Observation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

CONTACTChristiane Sokollik, Prof

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

PRINCIPAL_INVESTIGATORChristiane Sokollik, Prof

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026