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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
Study Summary
This trial is testing rifaximin, a drug usually used to treat intestinal infections, to see if it can help treat microscopic colitis, a condition characterized by inflammation of the colon.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Histologic Response for Indications of Disease Severity
Number of Subject Experiencing Remission of MC Symptoms
Secondary outcome measures
Change of the MC Disease Activity Index (MCDAI)
Side effects data
From 2015 Phase 3 trial • 40 Patients • NCT0312419936%
Diarrhea
25%
Metallic Taste
14%
Headache
14%
Nausea
3%
abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
NorthShore University HealthSystem
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I've tried other drugs and it helps for a period and then flares up again.
PatientReceived no prior treatments
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