NCT04139577

FMT In High-Risk Acute GVHD After ALLO HCT

Fecal Microbiota Transplantation (FMT) in for the Treatment of High-Risk Acute Graft-Versus-Host Disease (GVHD) After Allogeneic Hematopoietic Cell Transplantation (HCT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this research study, the investigators are evaluating the effectiveness of Fecal Microbiota Transplant (FMT) treatment in high-risk acute GVHD. The investigators are evaluating the effectiveness of FMT (also known as 'stool transplantation' or 'fecal transplant') in being able to transfer gut organisms from a healthy donor to the patient. The investigators are also evaluating the ability of this treatment to improve or completely resolve the clinical symptoms (diarrhea, abdominal pain, rash, liver inflammation) that can occur with acute GVHD.This research study is a Pilot Study, which is the first time investigators are examining this intervention for treatment of acute GVHD. The FDA (the U.S. Food and Drug Administration) has not approved FMT for this use. The FDA has classified human stool as a biological agent and determined that its use in FMT therapy should be regulated to ensure patient safety. To use FMT to treat recurrent Clostridium difficile infection, the most common indication for FMT, does not require an investigation new drug permit. To use FMT for research or to treat any condition other than recurrent Clostridium difficile infection requires an investigation new drug permit. An investigation new drug permit has been obtained for this study. * After HCT, the body's microbiome (the natural existence of various bacteria and organisms) in the intestinal tract may be affected, in that the number and types of good bacteria is reduced (also called a reduction in microbial flora diversity). Studies have shown that the number and types of good bacteria in the gut can impact whether or not graft-versus-host disease (GVHD) is developed. GVHD occurs when donated bone marrow cells attack the body with an immune response. * FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur the body. Since may have decreased microbial flora diversity after HCT, these microbial components are taken from a stool donor. They are extracted from fecal matter (stool) and put into a capsule to ingest.

Conditions

• Acute Graft-Versus-Host Disease (Gvhd) Grade
• Hematopoietic Cell Transplantation
• Fecal Microbiota Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	FMT- Oral Study Drug, predetermined dosage and timings, up to 2 cycles

Timeline

• Start date: 2021-06-18
• Primary completion: 2022-08-03
• Completion: 2023-01-05
• First posted: 2019-10-25
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study