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

Last updated: April 14, 2021
Sponsor: Eugene F Yen, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT04043897
EH17-360
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsiesreviewed by 2 separate pathologists
  • CC will be defined histologically to be the following: thickness of the collagenoussubepithelial table >10 micrometer using an ocular micrometer, inflammation in thelamina propria consisting of mainly lymphocytes and plasma cells, lack of cryptarchitectural distortion, and regenerative-appearing changes in the surface and/orcrypt epithelium
  • LC will be defined histologically to be the following: intraepithelial lymphocytes >20per 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 daysover >4 weeks in the past 3 months.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 10
Study Start date:
June 29, 2018
Estimated Completion Date:
December 31, 2021

Study 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).

Connect with a study center

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Active - Recruiting

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