Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Subject Experiencing Remission of MC Symptoms
Study Overview
Brief Summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
Detailed Description
This is an open-label single-arm trial to evaluate the efficacy of Rifaximin in patients with active microscopic colitis (MC). 10 subjects will be asked to take 500mg Rifaximin three times per day for 4 weeks. The primary endpoints will be histologic response and clinical remission (less than 3 stools per day and less than 1 watery stool per day within the prior 7 days. The secondary endpoint will be change of the MC Disease Activity Index (MCDAI).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Drug
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
Intervention: Rifaximin 550mg (Drug)
Outcomes
Primary Outcomes
Number of Subject Experiencing Remission of MC Symptoms
Time Frame: 6 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 Severity
Time Frame: 6 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.
Secondary Outcomes
- Change of the MC Disease Activity Index (MCDAI)(6 weeks)
Investigators
Eugene F Yen, MD
Clinical Associate Professor of Medicine
NorthShore University HealthSystem