FMT in Gut aGVHD Treated
Department of Hematology of First Affiliated Hospital of Soochow University
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
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
May 5, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 19, 2025
March 1, 2025
8.6 years
May 5, 2017
March 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
times of stool
Change from stool times in a week
24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Secondary Outcomes (1)
volume in milliliter of stool
24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Interventions
fecal microbiota transplantation
Eligibility Criteria
After stem cell transplantating , some patients suffered the gut GVHD were recuited
You may qualify if:
- gut GVHD
You may not qualify if:
- Age\>60; or Age\<10
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
中国
Suzhou, Jiangsu, 215006, China
Related Publications (3)
Liu Y, Zhao Y, Qi J, Ma X, Qi X, Wu D, Xu Y. Fecal microbiota transplantation combined with ruxolitinib as a salvage treatment for intestinal steroid-refractory acute GVHD. Exp Hematol Oncol. 2022 Nov 9;11(1):96. doi: 10.1186/s40164-022-00350-6.
PMID: 36352455DERIVEDZhao Y, Li X, Zhou Y, Gao J, Jiao Y, Zhu B, Wu D, Qi X. Safety and Efficacy of Fecal Microbiota Transplantation for Grade IV Steroid Refractory GI-GvHD Patients: Interim Results From FMT2017002 Trial. Front Immunol. 2021 Jun 17;12:678476. doi: 10.3389/fimmu.2021.678476. eCollection 2021.
PMID: 34220825DERIVEDQi 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.
PMID: 30319644DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
depei wu
first affiliated of Soochow university
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 5, 2017
First Posted
May 11, 2017
Study Start
May 16, 2017
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share