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

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

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.