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Efficacy and Safety of Auto-FMT in Preventing aGVHD

Primary Purpose

Graft Versus Host Disease, Acute

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
autologous fecal bacteria
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Versus Host Disease, Acute

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Ye ZhaoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with auto-FMT

empty capsule

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acute Graft-Versus-Host Disease

Secondary Outcome Measures

overall survival
Event free survival

Full Information

First Posted
February 3, 2021
Last Updated
February 17, 2023
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT04745221
Brief Title
Efficacy and Safety of Auto-FMT in Preventing aGVHD
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with auto-FMT
Arm Type
Experimental
Arm Description
The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation.
Arm Title
empty capsule
Arm Type
No Intervention
Arm Description
The patients in this group took empty capsule about 3 weeks after bone marrow transplantation
Intervention Type
Other
Intervention Name(s)
autologous fecal bacteria
Intervention Description
autologous fecal bacteria transplantation
Primary Outcome Measure Information:
Title
Acute Graft-Versus-Host Disease
Time Frame
90 days after haploidentical hematopoietic stem cell transplantation
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
90 days after haploidentical hematopoietic stem cell transplantation
Title
Event free survival
Time Frame
90 days after haploidentical hematopoietic stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ye Zhao
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Zhao
Phone
+8651267780410
Email
mutation@163.com

12. IPD Sharing Statement

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Efficacy and Safety of Auto-FMT in Preventing aGVHD

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