NCT03549676

Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory graft-versus-host-disease (GVHD) of the gut. FMT might be a beneficial treatment in this clinical situation 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 have a gastrointestinal acute GVHD received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. Therefore, the investigation of 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 refractory GVHD of the gut. FMT might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Conditions

• Fecal Microbiota Transplantation in GVHD

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	For patients who do not respond or partial respond for first time FMT treatment, a second time FMT treatment using different donor should be considered.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-05-31
• Completion: 2020-12-31
• First posted: 2018-06-08
• Last updated: 2019-03-26