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Recruiting

NCT Number: NCT04745221

Efficacy and Safety of Auto-FMT in Preventing aGVHD

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous fecal bacteria

Other

autologous fecal bacteria transplantation

Primary outcomes

  1. Acute Graft-Versus-Host Disease

    Time frame: 90 days after haploidentical hematopoietic stem cell transplantation

Secondary outcomes

  1. overall survival

    Time frame: 90 days after haploidentical hematopoietic stem cell transplantation

  2. Event free survival

    Time frame: 90 days after haploidentical hematopoietic stem cell transplantation

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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