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Rifaximin-treatment of Collagenous Colitis

NCT03658993 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-09-06

No results posted yet for this study

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.

Conditions

  • Collagenous Colitis

Interventions

DRUG

Rifaximin 550 MG

Oral Rifaximin 550 mg TID for 4 weeks.

Sponsors & Collaborators

  • Bonderup, Ole K., M.D.

    lead INDIV

Principal Investigators

  • Sabine K Becker, MD · Clinic of Gastrointestinal- and Infectious Diseases, Diagnostic Center Silkeborg Regional Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658993 on ClinicalTrials.gov