Status:
RECRUITING
Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Lead Sponsor:
Eugene F Yen, MD
Conditions:
Microscopic Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
June 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04043897
Start Date
June 29 2018
End Date
December 1 2021
Last Update
April 15 2021
Active Locations (1)
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1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201