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NCT02424175 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02424175 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants.
The verdict
NCT02424175, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2 who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use
Interventions
- BIOLOGICAL Fecal Microbiota Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2018-05-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02424175
The ClinicalTrials.gov registry entry for NCT02424175 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT02424175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02424175 about?
NCT02424175 is a clinical study titled "Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.". This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2 who also have concurrent...
What is the current status of trial NCT02424175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-02-01. Estimated completion is 2018-05-08.
What interventions are being tested in trial NCT02424175?
The interventions under investigation include: Fecal Microbiota Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02424175?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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