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NCT03678493 · ClinicalTrials.gov registry record · Phase 2
A Study of FMT in Patients With AML Allo HSCT in Recipients
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03678493 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 100 participants.
The verdict
NCT03678493, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.
Interventions
- OTHER Placebo
- BIOLOGICAL Fecal Microbiota Transplant (FMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2023-12-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03678493
The ClinicalTrials.gov registry entry for NCT03678493 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03678493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03678493 about?
NCT03678493 is a clinical study titled "A Study of FMT in Patients With AML Allo HSCT in Recipients". This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receiv...
What is the current status of trial NCT03678493?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2019-09-09. Estimated completion is 2023-12-04.
What interventions are being tested in trial NCT03678493?
The interventions under investigation include: Placebo (OTHER), Fecal Microbiota Transplant (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03678493?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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