NCT03214289

Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease

Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD. The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant.

Timeline

• Start date: 2017-07-12
• Primary completion: 2019-07-20
• Completion: 2019-12-20
• First posted: 2017-07-11
• Last updated: 2018-04-09

Locations

1 site across 1 country: Israel