drugset / Trial / NCT03658993

Rifaximin-treatment of Collagenous Colitis

NCT03658993

Phase 3 Unknown 50 enrolled Bonderup, Ole K., M.D.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-11-01
Primary completion
2020-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rifaximin Other / unclassified 550 mg Oral

Indications