NCT04043897 Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
| NCT ID | NCT04043897 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eugene F Yen, MD |
| Condition | Microscopic Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2018-06-29 |
| Primary Completion | 2021-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2018-06-29 with a primary completion date of 2021-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
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: \-
Contact & Investigator
Eugene Yen, MD
PRINCIPAL INVESTIGATOR
Endeavor Health
Frequently Asked Questions
Who can join the NCT04043897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Microscopic Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04043897 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04043897 currently recruiting?
Yes, NCT04043897 is actively recruiting participants. Contact the research team at damusin@northshore.org for enrollment information.
Where is the NCT04043897 trial being conducted?
This trial is being conducted at Evanston, United States.
Who is sponsoring the NCT04043897 clinical trial?
NCT04043897 is sponsored by Eugene F Yen, MD. The principal investigator is Eugene Yen, MD at Endeavor Health. The trial plans to enroll 10 participants.