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

Not Applicable

Completed

• Conditions: GVHD

• Registration Number: NCT06938165
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	12 weeks	Assessment of ORR (ORR = Complete Response (CR) + Partial Response (PR)) at 12 weeks after treatment. CR was defined as the complete resolution of all disease manifestations in every affected organ or site. PR was defined as an improvement in at least one organ or site without any disease progression occurring in other organs or sites.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing an Adverse Event (AE)	12 weeks	An adverse event refers to any unfavorable and unintended sign, symptom, or illness temporally associated with the use of the product, regardless of whether it is considered related to the product. A serious adverse event (SAE) is defined as an AE that results in death, is life-threatening, causes persistent or significant disability/incapacity, necessitates or extends hospitalization.

Trial Locations

Locations (1)

Nanfang hospital; 🇨🇳 Guangzhou, Guangdong, China