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NCT04139577 · ClinicalTrials.gov registry record · Phase 1
FMT In High-Risk Acute GVHD After ALLO HCT
A Phase 1 study of Hematopoietic Cell Transplantation and Acute Graft-Versus-Host Disease (Gvhd) Grade, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04139577: Completed Phase 1 study of Hematopoietic Cell Transplantation and Acute Graft-Versus-Host Disease (Gvhd) Grade, sponsored by Massachusetts General Hospital.
NCT04139577 is a Phase 1 study of Hematopoietic Cell Transplantation and Acute Graft-Versus-Host Disease (Gvhd) Grade that has completed, run by Massachusetts General Hospital. The registered enrollment target is 10 participants, below the 237-participant average among 4 other Hematopoietic Cell Transplantation trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139577, a Phase 1 study of Hematopoietic Cell Transplantation and Acute Graft-Versus-Host Disease (Gvhd) Grade, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) treatment in high-risk acute graft-versus-host disease (GVHD). This research study involves an experimental intervention called FMT.
Primary Outcome
Based on this information, FMT will be considered feasible if, among the 11 eligible patients, ≥8 patients are able to swallow ≥ 40 capsules.
Conditions Studied
Interventions
- BIOLOGICAL Fecal Microbiota Transplant
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-06-18 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 1 |
What the finished NCT04139577 record still lists
NCT04139577 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 237-participant average among 4 other Hematopoietic Cell Transplantation trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Hematopoietic Cell Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Fecal Microbiota Transplant is the first listed.
NCT04139577 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04139577 about?
NCT04139577 is a clinical study titled "FMT In High-Risk Acute GVHD After ALLO HCT". The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) treatment in high-risk acute graft-versus-host disease (GVHD). This research study involves an experimental intervention called FMT.
What is the current status of trial NCT04139577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-06-18. Estimated completion is 2023-01-05.
What conditions does trial NCT04139577 study?
This clinical trial studies the following conditions: Hematopoietic Cell Transplantation, Acute Graft-Versus-Host Disease (Gvhd) Grade, Fecal Microbiota Transplant.
What interventions are being tested in trial NCT04139577?
The interventions under investigation include: Fecal Microbiota Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT04139577?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04139577 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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