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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: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT03678493 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
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 |
What the finished NCT03678493 record still lists
NCT03678493 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03678493 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03678493's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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