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

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

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.

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.

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