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Antibiotic
Drug for Microscopic Colitis
Phase 2
Recruiting
Led By Eugene Yen, MD
Research Sponsored by Eugene F Yen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing the antibiotic rifaximin for treating microscopic colitis, a condition causing frequent and watery stools. The study involves patients taking the medication regularly over a period of weeks. The goal is to see if it reduces inflammation and improves symptoms by lowering gut bacteria levels. Rifaximin is a non-absorbable antibiotic derived from rifamycin, used to treat various intestinal bacterial infections and inflammatory bowel diseases.
Eligible Conditions
- Microscopic Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Histologic Response for Indications of Disease Severity
Number of Subject Experiencing Remission of MC Symptoms
Secondary study objectives
Change of the MC Disease Activity Index (MCDAI)
Side effects data
From 2015 Phase 3 trial • 40 Patients • NCT0312419936%
Diarrhea
25%
Metallic Taste
14%
Nausea
14%
Headache
3%
abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DrugExperimental Treatment1 Intervention
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
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Who is running the clinical trial?
Eugene F Yen, MDLead Sponsor
Eugene Yen, MDPrincipal InvestigatorNorthShore University HealthSystem
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