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NCT02464020 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
A Phase 1 study of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT02464020: Completed Phase 1 study of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis, sponsored by University of Minnesota.
NCT02464020 is a Phase 1 study of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis that has completed, run by University of Minnesota. The registered enrollment target is 8 participants, below the 404-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464020, a Phase 1 study of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. The investigators will also assess the blood and stool of healthy people, and people with IBD (without PSC) as a control group.
Primary Outcome
Fecal samples will be collected over 1 week. Bile acids will be measured on each sample and the average composition of primary to secondary bile acids over the 5 day period will be assessed. Comparison will be made pre and post vancomycin
Conditions Studied
Interventions
- DRUG Vancomycin
Study Locations (1)
Minnesota
- University of Minnesota Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-12-01 |
| Phase | Phase 1 |
What the finished NCT02464020 record still lists
NCT02464020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 404-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Inflammatory Bowel Disease appearing as the primary indexed condition, and to 1 intervention - of which Vancomycin is the first listed.
NCT02464020 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02464020 about?
NCT02464020 is a clinical study titled "A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis". The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course...
What is the current status of trial NCT02464020?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-07. Estimated completion is 2018-12-01.
What conditions does trial NCT02464020 study?
This clinical trial studies the following conditions: Inflammatory Bowel Disease, Primary Sclerosing Cholangitis.
What interventions are being tested in trial NCT02464020?
The interventions under investigation include: Vancomycin (DRUG).
Who is sponsoring clinical trial NCT02464020?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02464020 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02464020's enrollment target sits among peer trials
8 29th of 28 the lowest of 28 other Inflammatory Bowel Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Disease 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.
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