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

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: GVHD

Treatments: Other: Fecal Microbiota Transplant (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06938165

NFEC-2020-194

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. life-threatening or associated with severe non-GvHD complications;
2. Persistent malignant conditions;
3. Patients who have undergone second or multiple hematopoietic stem cell transplants;
4. History of severe allergic reactions;
5. 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);

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Patients with refractory graft-versus-host disease

Experimental group

Description:

FMT for patients with refractory GVHD

Treatment:

Other: Fecal Microbiota Transplant (FMT)