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Completed

NCT Number: NCT06938165

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

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

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Key information

Conditions

GVHD

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang hospital

Guangzhou, Guangdong, 520000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • 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);

Treatment and study plan

Fecal Microbiota Transplant (FMT)

Other

FMT in patients with refractory GVHD

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Acronym: FMT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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