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Rifaximin for Active Microscopic Colitis

This study is looking at how well and how safely the oral medication Rifaximin 550mg works for people with active microscopic colitis (MC). MC is a condition that causes inflammation in the colon, specifically collagenous colitis (CC) or lymphocytic colitis (LC). To join, you must be an adult with a confirmed diagnosis of CC or LC based on colon biopsies. The researchers will know if the treatment is successful by checking if your MC symptoms improve (clinical remission) and if there are positive changes in your colon tissue (histologic response) after 6 weeks. The study is currently unclear on its recruitment status.

Study design
This is an open-label, single-arm study, meaning all 10 participants will receive the Rifaximin treatment, and everyone involved will know what treatment is being given.
What's involved
You would take 500mg of Rifaximin three times per day for 4 weeks. Your symptoms and colon tissue would be evaluated after 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main evaluations for the study are measured at 6 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04043897

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Eugene F Yen, MD
~10 participants
Updated 2021-04-15 on ClinicalTrials.gov
What's tested:Rifaximin 550mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Subject Experiencing Remission of MC Symptoms
Measured over 6 weeks
+1 more outcome measured

Conditions

Microscopic Colitis

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NCT04043897

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NorthShore University HealthSystem

    Evanston, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eugene Yen, MD · PRINCIPAL_INVESTIGATOR · Endeavor Health

Who to contact

Daniel Amusin, BS
[email protected]
847-570-3558
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Number of Subject Experiencing Remission of MC Symptoms6 weeks

    Remission, which will be define as less than 3 stools per day and less than 1 watery stool per day within the prior 7 days as per Hjortswang criteria, which has been used as the standard definition of remission in most all randomized clinical trials evaluating budesonide and MC. Investigators will also look at number of bowel movements, abdominal pain, incontinence, and nocturnal bowel movements. Symptoms will be compared at Week 0 and Week 6.

  • Histologic Response for Indications of Disease Severity6 weeks

    Our institution has identified histologic parameters associated with more severe disease activity. In collaboration with pathologists, investigators will compare histologic inflammation on patients before and after treatment. Histology will be assessed via standard H\&E staining, specifically looking at surface epithelial changes associated with disease severity.