Efficacy and Safety of Auto-FMT in Preventing aGVHD

Soochow University

Status: Enrolling

Conditions: Graft Versus Host Disease, Acute

Treatments: Other: autologous fecal bacteria

Study type: Interventional

Funder types: Other

Identifiers

NCT04745221

FMT2021001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

with auto-FMT

Experimental group

Description:

The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation.

Treatment:

Other: autologous fecal bacteria

empty capsule

No Intervention group

Description:

The patients in this group took empty capsule about 3 weeks after bone marrow transplantation