FMT for Steroid Resistant Gut Acute GVHD

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Acute Graft-Versus-Host Disease; Stem Cell Transplant Complications; Fecal Microbiota Transplantation

Treatments: Biological: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04285424

FMT-GVHD-7182122

Details and patient eligibility

About

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Full description

Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.

  2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.

  3. Participants who accepted the FMT treatment. 4. Signature of informed and written consent by the subject.

Exclusion criteria

• 1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HSCT patients with acute steroid-resistant GI-related GVHD

Experimental group

Description:

Patients will receive 500ml fecal microbiota which were sprayed evenly on the entire colon through colonscopy or duodenal nutrition tube injection which collected from one unrelated healthy donors. Patients receiving FMT treatment will be followed for at least 1,3,5,7 days.Stool, blood and colonic mucosa samples will be serially collected and tested (before pre-treatment, 1,3,5,7 days after FMT).

Treatment:

Biological: Fecal Microbiota Transplantation