NCT04745221

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

February 3, 2021

Last Update Submit

December 24, 2025

Conditions

Graft Versus Host Disease, Acute

Outcome Measures

Primary Outcomes (1)

  • Acute Graft-Versus-Host Disease

    90 days after haploidentical hematopoietic stem cell transplantation

Secondary Outcomes (2)

  • overall survival

    90 days after haploidentical hematopoietic stem cell transplantation

  • Event free survival

    90 days after haploidentical hematopoietic stem cell transplantation

Study Arms (2)

with auto-FMT

EXPERIMENTAL

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

Other: autologous fecal bacteria

empty capsule

NO INTERVENTION

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

Interventions

autologous fecal bacteriaOTHER

autologous fecal bacteria transplantation

with auto-FMT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ye Zhao

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

CN(1)