CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Fecal Microbiota Transplant (FMT) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03678493
NCT03678493Phase 2Completed
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A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients

Masonic Cancer Center, University of Minnesota·interventional·Posted Sep 19, 2018·Updated May 16, 2024

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota Transplant (FMT) and Placebo for Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartSep 9, 2019
Primary CompletionFeb 11, 2022
Study CompletionDec 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.8 years ago

Interventions

Fecal Microbiota Transplant (FMT)biological

Oral Capsule

Placeboother

Oral Capsule