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

Recruiting now · Phase 2

Conditions studied: Microscopic Colitis

In brief

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

Key facts

Study ID

NCT04043897

Run by

Eugene F Yen, MD

People needed

10

Starts

2018-06-29

Expected to finish

2021-12-01

Last updated by the study team

2021-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• NorthShore University HealthSystem — Evanston, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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