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FMT for Steroid Resistant Gut Acute GVHD

NCT04285424 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-02

No results posted yet for this study

Summary

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Conditions

  • Stem Cell Transplant Complications
  • Acute Graft-Versus-Host Disease
  • Fecal Microbiota Transplantation

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

The fecal collection produced from a single healthy donor, unrelated to the patients

Sponsors & Collaborators

  • Beijing 302 Hospital

    collaborator OTHER

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-12-31
Completion
2022-03-01

Countries

  • China

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 NCT04285424 on ClinicalTrials.gov