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

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ClinicalTrials.gov Identifier: NCT04711967
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : August 31, 2021
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Graft Versus Host Disease in Intestine Biological: Fecal Microbiota Transplantation Drug: drug Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation group
treat with FMT
 Biological: Fecal Microbiota Transplantation
fecal microbiota transplantation
Active Comparator: Control group
treat with traditional medicine
 Drug: drug
drug


Outcome Measures
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Primary Outcome Measures :
  1. change in times of stool [ 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. ]
    Change in times of stool per day within 28 days after FMT

  2. change in volume of stool [ 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. ]
    Change in volume of stool per day within 28 days after FMT


Secondary Outcome Measures :
  1. Change in life quality up to 28 days [ 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. ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. uncontrolled or severe infections
  2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
  3. high-risk bleeding
  4. ANC<0.5×10^9/L or PLT<20x10^9/L
  5. hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
  6. patients participating in other clinical trials
  7. patienta who suffer from mental illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711967


Contacts
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Contact: Shuqian Xu +86 0531-88382169 shuqian.xu@email.sdu.edu.cn

Locations
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China, Beijing
Peking university people's hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Meng p Lv    13701140918      
China, Shandong
Shandong university qilu hospital Not yet recruiting
Jinan, Shandong, China, 250012
Contact: Shuqian Xu, Ph. D, M. D.    18560087013    shuqian.xu@email.sdu.edu.cn   
Sponsors and Collaborators
Qilu Hospital of Shandong University
Peking University People's Hospital
Investigators
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Principal Investigator: Shuqian Xu Qilu Hospital of Shandong University
More Information
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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04711967    
Other Study ID Numbers: 2020SDUCRCC015
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qilu Hospital of Shandong University:
Acute-graft-versus-host Disease
Fecal microbiota transplantation
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases