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Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Primary Purpose

Acute Graft Versus Host Disease in Intestine

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Fecal Microbiota Transplantation

drug

About this trial

This is an interventional treatment trial for Acute Graft Versus Host Disease in Intestine focused on measuring Acute-graft-versus-host Disease, Fecal microbiota transplantation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

received allo-HSCT due to a hematopoietic disease
corticosteroid resistant/dependent intestinal GVHD
ECOG≤2
Sign informed Consent
No major organ dysfunction

Exclusion Criteria:

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

Sites / Locations

Peking university people's hospitalRecruiting
Shandong university qilu hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fecal Microbiota Transplantation group

Control group

Arm Description

treat with FMT

treat with traditional medicine

Outcomes

Primary Outcome Measures

change in times of stool

Change in times of stool per day within 28 days after FMT

change in volume of stool

Change in volume of stool per day within 28 days after FMT

Secondary Outcome Measures

Change in life quality up to 28 days

The change quality of patients life within 28 days after FMT is assessed by "EORTC Quality of Life measurement Scale QLQ-C30 (V3.0)" with a score ranged 0~100. And the higher the score, the better the functional status and quality of life

Full Information

NCT ID

NCT04711967

First Posted

December 30, 2020

Last Updated

August 30, 2021

Sponsor

Qilu Hospital of Shandong University

Collaborators

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04711967

Brief Title

Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Official Title

Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qilu Hospital of Shandong University

Collaborators

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Graft Versus Host Disease in Intestine

Keywords

Acute-graft-versus-host Disease, Fecal microbiota transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fecal Microbiota Transplantation group

Arm Type

Experimental

Arm Description

treat with FMT

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

treat with traditional medicine

Intervention Type

Biological

Intervention Name(s)

Fecal Microbiota Transplantation

Intervention Description

fecal microbiota transplantation

Intervention Type

Drug

Intervention Name(s)

drug

Intervention Description

drug

Primary Outcome Measure Information:

Title

change in times of stool

Description

Change in times of stool per day within 28 days after FMT

Time Frame

day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.

Title

change in volume of stool

Description

Change in volume of stool per day within 28 days after FMT

Time Frame

day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.

Secondary Outcome Measure Information:

Title

Change in life quality up to 28 days

Description

Time Frame

day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: received allo-HSCT due to a hematopoietic disease corticosteroid resistant/dependent intestinal GVHD ECOG≤2 Sign informed Consent No major organ dysfunction Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shuqian Xu

Phone

+86 0531-88382169

shuqian.xu@email.sdu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuqian Xu

Organizational Affiliation

Qilu Hospital of Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking university people's hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng p Lv

Phone

13701140918

Facility Name

Shandong university qilu hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuqian Xu, Ph. D, M. D.

Phone

18560087013

shuqian.xu@email.sdu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

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