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NCT03148743 Clinical Trial

Fecal Microbiota Transplantation in Gut aGVHD Treated

Acute-graft-versus-host Disease Clinical Trial

Official title:
Department of Hematology of First Affiliated Hospital of Soochow University

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03148743
Other study ID # FMT2017002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 16, 2017
Est. completion date December 2025

Study information
Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact xiaofei qi
Phone 1-86-512-67780410
Email qixiaofei@suda.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 60 Years
Eligibility Inclusion Criteria: - gut GVHD Exclusion Criteria: - Age>60; or Age<10

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Fecal microbiota
fecal microbiota transplantation

Locations
Country Name City State
China ?? Suzhou Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary times of stool Change from stool times in a week 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Secondary volume in milliliter of stool Change from stool volume in a week 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
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