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

Who is this study for? Patients with Microscopic Colitis
What treatments are being studied? Rifaximin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
NorthShore University HealthSystem
RECRUITING
Evanston
Contact Information
Primary
Daniel Amusin, BS
damusin@northshore.org
847-570-3558
Backup
Iris Chiou, BA
ichiou@northshore.org
847-570-2138
Time Frame
Start Date: 2018-06-29
Estimated Completion Date: 2021-12
Participants
Target number of participants: 10
Treatments
Experimental: Drug
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
Sponsors
Leads: Eugene F Yen, MD

This content was sourced from clinicaltrials.gov

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