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Fecal Microbiota Transplantation in Gut aGVHD Treated

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ClinicalTrials.gov Identifier: NCT03148743
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Qi Xiao-Fei, The First Affiliated Hospital of Soochow University

Brief 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.

Condition or disease Intervention/treatment
Acute-graft-versus-host Disease Biological: Fecal microbiota

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Department of Hematology of First Affiliated Hospital of Soochow University
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2020



Intervention Details:
  • Biological: Fecal microbiota
    fecal microbiota transplantation


Primary Outcome Measures :
  1. times of stool [ Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week ]
    Change from stool times in a week


Secondary Outcome Measures :
  1. volume in milliliter of stool [ Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week ]
    Change from stool volume in a week



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
After stem cell transplantating , some patients suffered the gut GVHD were recuited
Criteria

Inclusion Criteria:

  • gut GVHD

Exclusion Criteria:

  • Age>60; or Age<10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148743


Contacts
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Contact: xiaofei qi 1-86-512-67780410 qixiaofei@suda.edu.cn

Locations
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China, Jiangsu
中国 Recruiting
Suzhou, Jiangsu, China, 215006
Contact: xiaofei qi    051265223637    qixiaofei@suda.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Study Chair: depei wu first affiliated of Soochow university

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qi Xiao-Fei, Principal Investigator, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03148743     History of Changes
Other Study ID Numbers: FMT2017002
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases