Health TrialsbyHealthPanel

Efficacy and Safety of Auto-FMT in Preventing aGVHD

ConditionGraft Versus Host Disease, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Haplo-HSCT patients; Bacteroidetes >0.1%; inverse Simpson diversity ≥2

Disqualifiers

Gastrointestinal diseases；Age>60; or Age<10；Probiotics or prebiotics were taken before enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • autologous fecal bacteria

    Other intervention

    autologous fecal bacteria transplantation

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: with auto-FMTExperimental treatment 1 intervention
Group B: empty capsuleNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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