RecruitingPhase 2NCT04043897

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


Sponsor

Eugene F Yen, MD

Enrollment

10 participants

Start Date

Jun 29, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • \-

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Interventions

DRUGRifaximin 550mg

Rifaximin 550mg


Locations(1)

NorthShore University HealthSystem

Evanston, Illinois, United States

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NCT04043897


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