Overview

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Eugene F Yen, MD

Treatments:

Rifaximin

Criteria

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 cells in the subjective area of highest lymphocyte density,
inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells,
and regenerative-appearing changes in the surface and/or crypt epithelium

- Subjects in active flare, defined as >3 watery/loose stools per day on >4 / 7 days
over >4 weeks in the past 3 months.

Exclusion Criteria:

-