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

Recruiting in Palo Alto (17 mi)

Overseen by Eugene Yen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eugene F Yen, MD

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing the antibiotic rifaximin for treating microscopic colitis, a condition causing frequent and watery stools. The study involves patients taking the medication regularly over a period of weeks. The goal is to see if it reduces inflammation and improves symptoms by lowering gut bacteria levels. Rifaximin is a non-absorbable antibiotic derived from rifamycin, used to treat various intestinal bacterial infections and inflammatory bowel diseases.

Eligibility Criteria

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

Participant Groups

Group I: Drug Experimental Treatment 1 Intervention

Patients will receive open-label rifaximin 550mg tid x 4 weeks.

Rifaximin is already approved in United States, Canada, European Union, India for the following indications:

🇺🇸 Approved in United States as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

🇨🇦 Approved in Canada as Zaxine for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

🇪🇺 Approved in European Union as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

🇮🇳 Approved in India as Ciboz and Xifapill for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NorthShore University HealthSystem Evanston, IL

Who Is Running the Clinical Trial?

Eugene F Yen, MD Lead Sponsor

References