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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Inflamatory Bowel Disease

Treatments: Other: Probiotic Formula; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT07533890

6110

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Probiotic

Experimental group

Description:

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

Treatment:

Other: Probiotic Formula

Observation

Other group

Description:

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

Treatment:

Other: Observation