Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis (NCT04043897) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
United States10 participantsStarted 2018-06-29
Plain-language summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
Who can participate
Age range18 Years
SexALL
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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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What they're measuring
1
Number of Subject Experiencing Remission of MC Symptoms
Timeframe: 6 weeks
2
Histologic Response for Indications of Disease Severity