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

NCT ID: NCT06938165

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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GVHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with refractory graft-versus-host disease

FMT for patients with refractory GVHD

Group Type EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type OTHER

FMT in patients with refractory GVHD

Interventions

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Fecal Microbiota Transplant (FMT)

FMT in patients with refractory GVHD

Intervention Type OTHER

Eligibility Criteria

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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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40859356 (View on PubMed)

Other Identifiers

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NFEC-2020-194

Identifier Type: -

Identifier Source: org_study_id

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