Efficacy and Safety of Auto-FMT in Preventing aGVHD

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04745221

Enrollment

100

Registered

2021-02-09

Start date

2021-03-01

Completion date

2027-03-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease, Acute

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.

Interventions

OTHERautologous fecal bacteria

autologous fecal bacteria transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
overall survival	90 days after haploidentical hematopoietic stem cell transplantation
Event free survival	90 days after haploidentical hematopoietic stem cell transplantation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026