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NCT04043897 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
A Phase 2 study of Microscopic Colitis, sponsored by Eugene F Yen, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04043897: Recruiting Phase 2 study of Microscopic Colitis, sponsored by Eugene F Yen, MD.
NCT04043897 is a Phase 2 study of Microscopic Colitis that is actively recruiting participants, run by Eugene F Yen, MD. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04043897, a Phase 2 study of Microscopic Colitis, is actively recruiting participants, sponsored by Eugene F Yen, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Rifaximin 550mg
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2021-12 |
| Phase | Phase 2 |
What NCT04043897 shows while recruiting
NCT04043897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Microscopic Colitis appearing as the primary indexed condition, and to 1 intervention - of which Rifaximin 550mg is the first listed.
NCT04043897 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04043897 about?
NCT04043897 is a clinical study titled "Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis". This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
What is the current status of trial NCT04043897?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-06-29. Estimated completion is 2021-12.
What conditions does trial NCT04043897 study?
This clinical trial studies the following conditions: Microscopic Colitis.
What interventions are being tested in trial NCT04043897?
The interventions under investigation include: Rifaximin 550mg (DRUG).
Who is sponsoring clinical trial NCT04043897?
This trial is sponsored by Eugene F Yen, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04043897 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04043897's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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