Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rifaximin 550mg.
- Who it may be relevant to
- Registry conditions: Microscopic Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Drug Rifaximin 550mg
Rifaximin 550mg
Primary outcome measures
- Number of Subject Experiencing Remission of MC Symptoms [Time frame: 6 weeks]
- Histologic Response for Indications of Disease Severity [Time frame: 6 weeks]
Secondary outcome measures (1)
- Change of the MC Disease Activity Index (MCDAI) [Time frame: 6 weeks]
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
- 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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NorthShore University HealthSystem — Evanston
Identifiers
NCT: NCT04043897 · EH17-360