Efficacy and Safety of Auto-FMT in Preventing aGVHD

May 28, 2026 updated by: Qi Xiao-Fei, The First Affiliated Hospital of Soochow University

Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study

To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • Ye Zhao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Haplo-HSCT patients; Bacteroidetes >0.1%; inverse Simpson diversity ≥2

Exclusion Criteria:

  • Gastrointestinal diseases；Age>60; or Age<10；Probiotics or prebiotics were taken before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with auto-FMT
The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation.
Other: autologous fecal bacteria
autologous fecal bacteria transplantation
No Intervention: empty capsule
The patients in this group took empty capsule about 3 weeks after bone marrow transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Graft-Versus-Host Disease
Time Frame: 90 days after haploidentical hematopoietic stem cell transplantation
90 days after haploidentical hematopoietic stem cell transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 90 days after haploidentical hematopoietic stem cell transplantation
90 days after haploidentical hematopoietic stem cell transplantation
Event free survival
Time Frame: 90 days after haploidentical hematopoietic stem cell transplantation
90 days after haploidentical hematopoietic stem cell transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT2021001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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