Efficacy and Safety of Auto-FMT in Preventing aGVHD

Not Applicable

Recruiting

• Conditions: Graft Versus Host Disease, Acute
• Interventions: Other: autologous fecal bacteria

• Registration Number: NCT04745221
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-09
• Study Start: 2021-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
with auto-FMT	autologous fecal bacteria	The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation.

Primary Outcome Measures

Name	Time	Method
Acute Graft-Versus-Host Disease	90 days after haploidentical hematopoietic stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
overall survival	90 days after haploidentical hematopoietic stem cell transplantation
Event free survival	90 days after haploidentical hematopoietic stem cell transplantation

Trial Locations

Locations (1)

Ye Zhao; 🇨🇳 Suzhou, Jiangsu, China