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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    20
  • sponsor
    Qilu Hospital of Shandong University
Updated on 6 September 2021

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.

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.

Details
Condition Acute Graft Versus Host Disease in Intestine
Treatment Fecal Microbiota Transplantation, drug
Clinical Study IdentifierNCT04711967
SponsorQilu Hospital of Shandong University
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

received allo-HSCT due to a hematopoietic disease
corticosteroid resistant/dependent intestinal GVHD
ECOG2
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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<0.510^9/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
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