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NCT04745221 Clinical Trial

Efficacy and Safety of Auto-FMT in Preventing aGVHD

Graft Versus Host Disease, Acute Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04745221
Other study ID # FMT2021001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 1, 2026

Study information
Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 1, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• autologous fecal bacteria
autologous fecal bacteria transplantation

Locations
Country Name City State
China Ye Zhao Suzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Graft-Versus-Host Disease 90 days after haploidentical hematopoietic stem cell transplantation
Secondary overall survival 90 days after haploidentical hematopoietic stem cell transplantation
Secondary Event free survival 90 days after haploidentical hematopoietic stem cell transplantation
See also
  Status Clinical Trial Phase
Recruiting NCT05643638 - A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD Phase 2
Recruiting NCT03214289 - Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease Phase 1
Completed NCT04038827 - Origin of CEC in Patients After Allo-HSCT
Recruiting NCT05362630 - Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study