Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Eugene F Yen, MD
Summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
Description
This is an open-label single-arm trial to evaluate the efficacy of Rifaximin in patients with active microscopic colitis (MC). 10 subjects will be asked to take 500mg Rifaximin three times per day for 4 weeks. The primary endpoints will be histologic response and clinical remission (less than 3 stools per day and less than 1 watery stool per day within the prior 7 days. The secondary endpoint will be change of the MC Disease Activity Index (MCDAI).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists * CC will be defined histologically to be the following: thickness of the collagenous subepithelial table \>10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and/or crypt epithelium * LC will be defined histologically to be the following: intraepithelial lymphocytes \>20 per 100 epithelial c…
Interventions
- DrugRifaximin 550mg
Rifaximin 550mg
Location
- NorthShore University HealthSystemEvanston, Illinois