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Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD (FEMITGIGVHD)

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fecal microbiome transplantation
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematopoietic and Lymphoid Cell Neoplasm focused on measuring allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age>= 14 yrs ≤60 yrs.
  2. Diagnosed with hematological diseases.
  3. Recipients of allogeneic peripheral blood stem cell transplantation.
  4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
  5. Eastern Cooperative Oncology Group (ECOG) score ≤2;
  6. Signed consent form.

Exclusion Criteria:

  1. Complicated with uncontrolled severe infection except intestine and colon.
  2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
  3. Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
  4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
  5. Participating other clinical trials.
  6. Pregnant women.

Sites / Locations

  • Shanghai Jiao Tong University Affilated First People's HospitalRecruiting
  • Shanghai Jiao Tong University Affilated Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fecal microbiome transplantation

Arm Description

Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response; If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.

Outcomes

Primary Outcome Measures

Response rate
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.

Secondary Outcome Measures

Time to response
Time to response of acute gastrointestinal GVHD
Duration of response
Duration of response of acute gastrointestinal GVHD

Full Information

First Posted
January 19, 2019
Last Updated
March 15, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03812705
Brief Title
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Acronym
FEMITGIGVHD
Official Title
Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). Inclusion criteria: Age>= 14 yrs ≤60 yrs. Diagnosed with hematological diseases. Recipients of allogeneic peripheral blood stem cell transplantation. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction. ECOG score ≤2; signed consent form. Exclusion criteria: Complicated with uncontrolled severe infection except intestine and colon. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage; Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction. Participating other clinical trials. Pregnant women. Treatment: Stop antibiotics treatment 1 day before FMT; Fasting food 6 hours before FMT; Give Ondansetron intravenously 1 hour before FMT for vomiting prevention; Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response; If patient's condition is not improved after the second FMT, stop FMT. Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response. Minor endpoints: Time to response of acute gastrointestinal GVHD; Duration of response of acute gastrointestinal GVHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid Cell Neoplasm
Keywords
allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fecal microbiome transplantation
Arm Type
Experimental
Arm Description
Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response; If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.
Intervention Type
Biological
Intervention Name(s)
fecal microbiome transplantation
Intervention Description
Stop antibiotics treatment 1 day before fecal microbiome transplantation; Fasting food 6 hours before fecal microbiome transplantation; Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention; Perform fecal microbiome transplantation under colonoscopy or gastroscopy; Perform up to 4 times if patient response; Stop if no response after twice fecal microbiome transplantation.
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
Time Frame
12 weeks within FMT
Secondary Outcome Measure Information:
Title
Time to response
Description
Time to response of acute gastrointestinal GVHD
Time Frame
12 weeks within FMT
Title
Duration of response
Description
Duration of response of acute gastrointestinal GVHD
Time Frame
12 weeks within FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>= 14 yrs ≤60 yrs. Diagnosed with hematological diseases. Recipients of allogeneic peripheral blood stem cell transplantation. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction. Eastern Cooperative Oncology Group (ECOG) score ≤2; Signed consent form. Exclusion Criteria: Complicated with uncontrolled severe infection except intestine and colon. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage; Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction. Participating other clinical trials. Pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liping Wan, MD
Phone
862137798075
Email
wanliping924@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Zhou, MD
Phone
862137798987
Email
zhkzhw@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liping Wan, MD
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affilated First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingpeng Wang, M.D, Ph.D
Phone
63069298
Email
sfph_edu2@163.com
First Name & Middle Initial & Last Name & Degree
Yanhong Zhu, M.S
Phone
63240090
Ext
6213
Email
sfph_edu2@shmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Liping Wan, M.D., Ph.D.
Facility Name
Shanghai Jiao Tong University Affilated Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingpeng Wang, M.D, Ph.D
Phone
63069298
Email
sfph_edu2@163.com
First Name & Middle Initial & Last Name & Degree
Yanhong Zhu, M.S
Phone
63240090
Ext
6213
Email
sfph_edu2@shmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Liping Wan, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

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