In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
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
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.
Crossover
Probiotic Formula
Other interventionmulti-strain probiotics
Observation
Other interventionObservation
abundance of specific bacteria
operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3
microbiome analysis
diversity (Shannon Index) and composition (beta diversity metrics (Bray-Curtis dissimilarity)) at T0,T1,T2,T3
clinical response
clinical activity scores: ΔPUCAI for UC, ΔPCDAI for CD at T0,T1,T2,T3
laboratory response - local
fecal calprotection at T0,T1,T2,T3
laboratory response - systemic
Composite assessment of C-reactive protein, thrombocytes and ESR at T0,T1,T2,T3
quality of life in 9 -17 years of age
Impact III score at T0,T1,T2,T3
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
Clinical Trials Unit University of Bern
Collaborator
University of Bern
Collaborator
