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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: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT02424175 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of patients with reporting adverse events irregardless of severity
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 |
What the finished NCT02424175 record still lists
NCT02424175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplantation is the first listed.
NCT02424175 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02424175's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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