NCT03678493

A Study of FMT in Patients With AML Allo HSCT in Recipients

A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Allogeneic Hematopoietic Cell Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant (FMT)	Oral Capsule
OTHER	Placebo	Oral Capsule

Timeline

• Start date: 2019-09-09
• Primary completion: 2022-02-11
• Completion: 2023-12-04
• First posted: 2018-09-19
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study