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Clinical Trial Summary

The hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory process in the colonic mucosa leading to collagenous colitis. The investigators suggest that treatment with budesonide reduces the inflammation without treating the underlying cause. In this trial the investigators will try to modullate gut microbiota by adding rifaximin. The aim of this study is to assess if 4 weeks treatment with rifaximin as a supplement to a standard course of budesonide against active CC can reduce the risk of relapse after treatment cessation.


Clinical Trial Description

Patients with biopsy-verified CC and active disease defined by >3 bowel movements/day or >1 watery stool measured as a mean for a week. Patients will be invited to participate in the study independently of age and disease duration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03658993
Study type Interventional
Source Bonderup, Ole K., M.D.
Contact Ole K Bonderup, PhD
Phone 004520212579
Email olebonde@rm.dk
Status Not yet recruiting
Phase Phase 3
Start date November 1, 2018
Completion date November 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00139165 - Long-Term Treatment of Collagenous Colitis With Budesonide Phase 3
Completed NCT00450086 - Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis Phase 3
Recruiting NCT01504048 - Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis N/A
Completed NCT01928667 - Case-Control Study to Identify Risk Factors for Microscopic Colitis N/A
Completed NCT00180076 - Budesonide for Maintenance Treatment of Collagenous Colitis Phase 3