Status:

COMPLETED

The Safety and Efficacy of Fecal Microbiota Transplant (FMT) for Steroid-refractory Graft-versus-host Disease

Lead Sponsor:

Nanfang Hospital, Southern Medical University

Conditions:

GVHD

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).

Eligibility Criteria

Inclusion

  • Able and willing to sign the informed consent form and complete follow-up;
  • Aged 18-65 years, regardless of gender;
  • Patients with refractory GVHD.

Exclusion

  • life-threatening or associated with severe non-GvHD complications;
  • Persistent malignant conditions;
  • Patients who have undergone second or multiple hematopoietic stem cell transplants;
  • History of severe allergic reactions;
  • Any condition that the investigator considers unsuitable for inclusion (such as any history, treatment history, or abnormal test data that may confound the study results, interfere with full participation in the study, or harm the patient's interests);

Key Trial Info

Start Date :

April 27 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2024

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT06938165

Start Date

April 27 2020

End Date

June 30 2024

Last Update

April 22 2025

Active Locations (1)

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1

Nanfang hospital

Guangzhou, Guangdong, China, 520000