Using Rifaximin to treat active Microscopic Colitis
Official title: Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
Run by Endeavor Health · NCT04043897 · Data updated 2026-11-12
This study is testing if the antibiotic Rifaximin can help people with active microscopic colitis feel better and improve their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Status | Recruiting |
| Started | June 29, 2018 |
| Main results expected | December 2021 |
| Study ends | December 2021 |
| Registry record updated | April 15, 2021 |
| Trial ID | NCT04043897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with collagenous or lymphocytic colitis experiencing active flare-ups.
✕Probably not a fit
Patients without a confirmed diagnosis of microscopic colitis or those not experiencing active symptoms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-arm trial evaluates the efficacy of Rifaximin in patients diagnosed with active microscopic colitis, specifically collagenous or lymphocytic colitis. A total of 10 subjects will receive 500mg of Rifaximin three times daily for four weeks. The primary endpoints include histologic response and clinical remission, defined by stool frequency and consistency. Secondary endpoints will assess changes in the Microscopic Colitis Disease Activity Index (MCDAI).
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from active microscopic colitis.
How similar studies have gone: While this approach is novel for microscopic colitis, similar studies using Rifaximin for other gastrointestinal conditions have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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: \-
Where it's running
-
NorthShore University HealthSystem
Evanston, Illinois, United States Recruiting
Study contacts
- Principal investigator: Eugene Yen, MD — Endeavor Health
- Study coordinator: Daniel Amusin, BS
- Email: damusin@northshore.org
- Phone: 847-570-3558
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SAR444336 to help adults with microscopic colitis stay in remission while on budesonide.
This will test whether adding SAR444336 to budesonide helps adults with microscopic colitis who are in remission stay symptom-free longer than placebo.
-
See if PuraStat after Aquablation reduces bleeding and speeds discharge
This study tests whether applying PuraStat after Aquablation can reduce bleeding and allow more patients to go home the same day.
-
Structured social activities to help older adults overcome loneliness
This study tests whether a personalized plan of two hours per week of community activities can help adults 55 and older who feel lonely feel less lonely over six months.
-
Can a handheld nerve monitor detect early ICU weakness in healthy people and ICU patients
This study tests whether a non-invasive nerve monitor (TetraGraph) can spot early signs of ICU-acquired weakness by comparing its readings with standard nerve tests in healthy volunteers and ICU patients.
-
How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
-
Zinc plus phytase given before botulinum toxin injections for overactive bladder
This trial will test whether a short course of oral zinc plus phytase before botulinum toxin bladder injections helps adult women with overactive bladder go longer without needing another injection over six months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.