Back to resultsFMT for Steroid Resistant Gut Acute GVHD
Primary Purpose
Stem Cell Transplant Complications, Acute Graft-Versus-Host Disease, Fecal Microbiota Transplantation
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Stem Cell Transplant Complications
Eligibility Criteria
Inclusion Criteria:
1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.
2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.
3. Participants who accepted the FMT treatment. 4. Signature of informed and written consent by the subject.
Exclusion Criteria:
- 1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.
Sites / Locations
- Affiliated Hospital to Academy of Military Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HSCT patients with acute steroid-resistant GI-related GVHD
Arm Description
Patients will receive 500ml fecal microbiota which were sprayed evenly on the entire colon through colonscopy or duodenal nutrition tube injection which collected from one unrelated healthy donors. Patients receiving FMT treatment will be followed for at least 1,3,5,7 days.Stool, blood and colonic mucosa samples will be serially collected and tested (before pre-treatment, 1,3,5,7 days after FMT).
Outcomes
Primary Outcome Measures
Gut acute Graft-versus-Host Disease (aGvHD) response.
Participants will be evaluated within 7 days following transplantation for response to therapy.
Secondary Outcome Measures
Non-serious adverse events
Participants will be evaluated for non-serious adverse events relating to FMT within 7 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain.
aGvHD severity
Number of participants will be evaluated on 1，3，5, 7 days following transplantation for severity of aGvHD.
Number of participants with infectious disorders
Evaluation of FMT activity on infectious disorder.
Number of multidrug resistant bacteria in faeces
Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage
Change in microbiota composition after FMT
Evaluation of microbiota composition before and after FMT
Full Information
NCT ID
NCT04285424
First Posted
February 20, 2020
Last Updated
February 27, 2020
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing 302 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04285424
Brief Title
FMT for Steroid Resistant Gut Acute GVHD
Official Title
Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
Collaborators
Beijing 302 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.
Detailed Description
Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant Complications, Acute Graft-Versus-Host Disease, Fecal Microbiota Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HSCT patients with acute steroid-resistant GI-related GVHD
Arm Type
Experimental
Arm Description
Patients will receive 500ml fecal microbiota which were sprayed evenly on the entire colon through colonscopy or duodenal nutrition tube injection which collected from one unrelated healthy donors. Patients receiving FMT treatment will be followed for at least 1,3,5,7 days.Stool, blood and colonic mucosa samples will be serially collected and tested (before pre-treatment, 1,3,5,7 days after FMT).
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
The fecal collection produced from a single healthy donor, unrelated to the patients
Primary Outcome Measure Information:
Title
Gut acute Graft-versus-Host Disease (aGvHD) response.
Description
Participants will be evaluated within 7 days following transplantation for response to therapy.
Time Frame
1 day to 7 days following FMT
Secondary Outcome Measure Information:
Title
Non-serious adverse events
Description
Participants will be evaluated for non-serious adverse events relating to FMT within 7 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain.
Time Frame
1,3,5,7 days following FMTs
Title
aGvHD severity
Description
Number of participants will be evaluated on 1，3，5, 7 days following transplantation for severity of aGvHD.
Time Frame
1,3,5,7 days following FMT
Title
Number of participants with infectious disorders
Description
Evaluation of FMT activity on infectious disorder.
Time Frame
1,3,5,7 days following FMT
Title
Number of multidrug resistant bacteria in faeces
Description
Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage
Time Frame
1,3,5,7 days following FMT
Title
Change in microbiota composition after FMT
Description
Evaluation of microbiota composition before and after FMT
Time Frame
1,3,5,7 days months following FMT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.
2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.
3. Participants who accepted the FMT treatment. 4. Signature of informed and written consent by the subject.
Exclusion Criteria:
1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Min, MD
Phone
13426165452
Email
minmin823@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, MD
Phone
13911798288
Email
13911798288@163.com
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min min, Ph.D
Phone
01066947473
Email
minmin823@sina.com
12. IPD Sharing Statement
Learn more about this trial
FMT for Steroid Resistant Gut Acute GVHD
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