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Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD

NCT04059757 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-07-07

No results posted yet for this study

Summary

Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. You are being asked to take part in this study because you have recently been diagnosed with GI-GVHD. The standard of care for GI-aGVHD is steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD.

This study is a Phase II study. The main goal of a Phase II study is to see the efficacy and what side effects are seen with FMT as a treatment for GVHD.

Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection.

FMT is considered experimental in this study, meaning it is not approved by the FDA for the treatment of GVHD.

Conditions

  • Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD)

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation

Sponsors & Collaborators

  • Leland Metheny

    lead OTHER

Principal Investigators

  • Leland Metheny, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-06-30
Completion
2023-09-30
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 NCT04059757 on ClinicalTrials.gov