FMT In High-Risk Acute GVHD After ALLO HCT

NCT04139577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

FMT- Oral Study Drug, predetermined dosage and timings, up to 2 cycles

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Zachariah DeFilipp, MD · Masachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2022-08-03
Completion
2023-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139577 on ClinicalTrials.gov