NCT03658993

Rifaximin-treatment of Collagenous Colitis

Rifaximin-treatment of Collagenous Colitis:

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bonderup, Ole K., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Collagenous Colitis

Interventions

Type	Name	Description
DRUG	Rifaximin 550 MG	Oral Rifaximin 550 mg TID for 4 weeks.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2018-09-06
• Last updated: 2018-09-06