NCT05702879

Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.

Detailed description

The investigators perform a longitudinal prospective multi-center study for ulcerative colitis (UC) patients with a flare at/and after the time of starting a new treatment and healthy household controls. They will perform intense longitudinal bio-sampling and deep clinical characterization. With this information the aim is to develop a predictive signature regarding the success of a new ly started anti-inflammatory therapy after an UC flare.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Ozanimod	Start of standard therapy
DRUG	TNF Inhibitor	Start of standard therapy
DRUG	Steroids	Start of standard therapy
DRUG	Vedolizumab	Start of standard therapy
DRUG	Ustekinumab	Start of standard therapy

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-01-27
• Last updated: 2023-12-06

Locations

1 site across 1 country: Switzerland