Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT
Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
20
1 country
2
Brief Summary
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
2 active sites
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
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 31, 2021
January 1, 2021
2.3 years
December 30, 2020
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in times of stool
Change in times of stool per day within 28 days after FMT
day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
change in volume of stool
Change in volume of stool per day within 28 days after FMT
day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Secondary Outcomes (1)
Change in life quality up to 28 days
day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Study Arms (2)
Fecal Microbiota Transplantation group
EXPERIMENTALtreat with FMT
Control group
ACTIVE COMPARATORtreat with traditional medicine
Interventions
fecal microbiota transplantation
Eligibility Criteria
You may qualify if:
- received allo-HSCT due to a hematopoietic disease
- corticosteroid resistant/dependent intestinal GVHD
- ECOG≤2
- Sign informed Consent
- No major organ dysfunction
You may not qualify if:
- uncontrolled or severe infections
- patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
- high-risk bleeding
- ANC\<0.5×10\^9/L or PLT\<20x10\^9/L
- hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
- patients participating in other clinical trials
- patienta who suffer from mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking university people's hospital
Beijing, Beijing Municipality, 100044, China
Shandong university qilu hospital
Jinan, Shandong, 250012, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuqian Xu
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
January 15, 2021
Study Start
March 10, 2021
Primary Completion
July 1, 2023
Study Completion
December 31, 2023
Last Updated
August 31, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share