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NCT02741518 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation for the Treatment of Obesity
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02741518 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 22 participants.
The verdict
NCT02741518, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.
Interventions
- OTHER Placebo
- BIOLOGICAL Fecal Microbiota Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02741518
The ClinicalTrials.gov registry entry for NCT02741518 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 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 2 interventions - of which Placebo is the first listed.
NCT02741518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02741518 about?
NCT02741518 is a clinical study titled "Fecal Microbiota Transplantation for the Treatment of Obesity". This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing writte...
What is the current status of trial NCT02741518?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-04-01. Estimated completion is 2019-07-24.
What interventions are being tested in trial NCT02741518?
The interventions under investigation include: Placebo (OTHER), Fecal Microbiota Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02741518?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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