Recruiting
Phase 2

Rifaximin

Sponsor:

Eugene F Yen, MD

Code:

NCT04043897

Conditions

Microscopic Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rifaximin 550mg

Study Details

Brief summary:

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

Conditions

Microscopic Colitis

Study ID

NCT04043897

Start date

Jun 29, 2018

Status verified date

Apr, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug

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

Interventions

Rifaximin 550mg

Rifaximin 550mg

Primary outcome measure

  • Number of Subject Experiencing Remission of MC Symptoms [ Time Frame: 6 weeks ]
  • Histologic Response for Indications of Disease Severity [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Daniel Amusin, BS

847-570-3558damusin@northshore.org

Iris Chiou, BA

847-570-2138ichiou@northshore.org

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Daniel Amusin, BS

847-570-3558damusin@northshore.org

Iris Chiou, BA

847-570-2138ichiou@northshore.org

Principal Investigator:

Eugene Yen, MD

More Information

Sponsor

Eugene F Yen, MD

Last update posted

Apr 15, 2021

Last verified

Apr, 2021

Keywords

  • Microscopic Colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eugene F Yen, MD on 2021-04-15.