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Recruiting Phase 2 NCT04043897

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

Trial Parameters

Condition Microscopic Colitis
Sponsor Eugene F Yen, MD
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-06-29
Completion 2021-12
Interventions
Rifaximin 550mg

Brief Summary

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

Eligibility 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: \-

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