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

Shandong University

Status: Unknown

Conditions: Acute Graft Versus Host Disease in Intestine

Treatments: Drug: drug; Biological: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04711967

2020SDUCRCC015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Fecal Microbiota Transplantation group

Experimental group

Description:

treat with FMT

Treatment:

Biological: Fecal Microbiota Transplantation

Control group

Active Comparator group

Description:

treat with traditional medicine

Treatment:

Drug: drug