NCT04059757

Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD

Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute Graft Versus Host Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Leland Metheny · Academic / Other
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. You are being asked to take part in this study because you have recently been diagnosed with GI-GVHD. The standard of care for GI-aGVHD is steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD. This study is a Phase II study. The main goal of a Phase II study is to see the efficacy and what side effects are seen with FMT as a treatment for GVHD. Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection. FMT is considered experimental in this study, meaning it is not approved by the FDA for the treatment of GVHD.

Conditions

• Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD)

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation (FMT)	1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2019-08-16
• Last updated: 2022-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study