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

NCT06938165 | Completed

• 1 other identifier: NFEC-2020-194
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

GVHD

Keywords

GVHD

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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.

  12 weeks

Secondary Outcomes (1)

• Number of Participants Experiencing an Adverse Event (AE)

  12 weeks

Study Arms (1)

Patients with refractory graft-versus-host disease

EXPERIMENTAL

FMT for patients with refractory GVHD

Other: Fecal Microbiota Transplant (FMT)

Interventions

Fecal Microbiota Transplant (FMT) OTHER

FMT in patients with refractory GVHD

Patients with refractory graft-versus-host disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital

Guangzhou, Guangdong, 520000, China

Location

Related Publications (1)

• Yang K, Du J, Huang F, Si Y, Gu Y, Xu N, Fan Z, Xue R, Wang P, Yao X, Liu H, Li X, Xu J, Wang Z, Sun J, Chen Y, Xuan L, Liu Q. Fecal microbiota transplantation for refractory chronic graft-versus-host disease after allogeneic hematopoietic cell transplantation: a pilot open-label, non-placebo-controlled study. BMC Med. 2025 Aug 26;23(1):498. doi: 10.1186/s12916-025-04336-z.

  PMID: 40859356 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 22, 2025
• Study Start: April 27, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)