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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

Tracking Information
First Submitted Date May 5, 2017
First Posted Date May 11, 2017
Last Update Posted Date February 13, 2018
Actual Study Start Date May 20, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2017)
times of stool [ Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week ]
Change from stool times in a week
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03148743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 10, 2017)
volume in milliliter of stool [ Time Frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week ]
Change from stool volume in a week
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fecal Microbiota Transplantation in Gut aGVHD Treated
Official Title Department of Hematology of 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population After stem cell transplantating , some patients suffered the gut GVHD were recuited
Condition Acute-graft-versus-host Disease
Intervention Biological: Fecal microbiota
fecal microbiota transplantation
Study Groups/Cohorts Not Provided
Publications * Qi X, Li X, Zhao Y, Wu X, Chen F, Ma X, Zhang F, Wu D. Treating Steroid Refractory Intestinal Acute Graft-vs.-Host Disease With Fecal Microbiota Transplantation: A Pilot Study. Front Immunol. 2018 Sep 25;9:2195. doi: 10.3389/fimmu.2018.02195. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 10, 2017)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • gut GVHD

Exclusion Criteria:

  • Age>60; or Age<10
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: xiaofei qi 1-86-512-67780410 qixiaofei@suda.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03148743
Other Study ID Numbers FMT2017002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Qi Xiao-Fei, The First Affiliated Hospital of Soochow University
Study Sponsor The First Affiliated Hospital of Soochow University
Collaborators Not Provided
Investigators
Study Chair: depei wu first affiliated of Soochow university
PRS Account The First Affiliated Hospital of Soochow University
Verification Date July 2017