Fecal Microbiota Transplantation in Gut aGVHD Treated

April 8, 2024 updated by: Qi Xiao-Fei, The First Affiliated Hospital of Soochow University

Department of Hematology of First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

After stem cell transplantating , some patients suffered the gut GVHD were recuited

Description

Inclusion Criteria:

  • gut GVHD

Exclusion Criteria:

  • Age>60; or Age<10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
times of stool
Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Change from stool times in a week
24hours,48hours,72hours, 96hours,fifth day,sixth day, a week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume in milliliter of stool
Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Change from stool volume in a week
24hours,48hours,72hours, 96hours,fifth day,sixth day, a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: depei wu, first affiliated of Soochow university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT2017002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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