NCT04285424

FMT for Steroid Resistant Gut Acute GVHD

Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Stem Cell Transplant Complications
• Acute Graft-Versus-Host Disease
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	The fecal collection produced from a single healthy donor, unrelated to the patients

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-12-31
• Completion: 2022-03-01
• First posted: 2020-02-26
• Last updated: 2020-03-02

Locations

1 site across 1 country: China