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CompletedNCT06938165FMTUpdated Apr 22, 2025

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

An interventional study of Fecal Microbiota Transplant (FMT) in GVHD, sponsored by Nanfang Hospital, Southern Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Apr 2020, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • GVHD

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Keywords

  • GVHD
03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 46 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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);
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Patients with refractory graft-versus-host disease

    FMT for patients with refractory GVHD

    Other: Fecal Microbiota Transplant (FMT)

Interventions

  • OtherFecal Microbiota Transplant (FMT)

    FMT in patients with refractory GVHD

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What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. Number of Participants Experiencing an Adverse Event (AE)

    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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Nanfang hospital
    Guangzhou, Guangdong 520000, China
08

References and documents

Individual participant data

Plan to share: No — Only accept academic purpose for the sharing data and please contact PI with reasonable inquiring.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06938165
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Apr 27, 2020
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Apr 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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