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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02464020
The ClinicalTrials.gov registry entry for NCT02464020 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 404-participant average among 28 other Inflammatory Bowel Disease trials with a reported enrollment target (98% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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