NCT04280471

Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease

An Open-Label Phase 1 Pilot Study: Fecal Microbiota Transplantation (FMT) in Severe Acute Gut Graft-Versus-Host Disease Patients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of using an investigational procedure (fecal microbiota transplantation \[FMT\]) in treating patients with severe acute gut graft-versus-host-disease. The purpose of a fecal microbiota transplantation is to use feces from a healthy human donor to replace the abnormal gut bacteria in the recipient. One of the side effects of a stem cell transplant is the development of graft-versus-host disease (GvHD) in several organs including gut. GvHD is caused by the donated bone marrow or peripheral blood cells recognizing the recipient's body as foreign and attacking it. Acute gut GvHD is one of the leading causes of death after transplant. Recently, studies have shown that patients with reduced intestinal bacterial diversity in their stool during acute gut GvHD have higher overall mortality rates. The information learned from this study may offer FMT as a promising therapy for the treatment of severe acute gut graft-versus-host-disease.

Detailed description

PRIMARY OBJECTIVES: I. For safety evaluation, episodes of microbial bloodstream infection attributed to fecal microbiota transplantation (FMT) within the first 7 days after start of each FMT administration. II. For tolerability evaluation, subject must ingest 50% of one dose of FMT product without grade 3 or higher adverse events (AEs) within the first 7 days post-FMT. SECONDARY OBJECTIVE: I. To collect stool, oral swabs and blood specimens for future studies to define bacterial taxa diversity, microbial translocation as well as metabolomic and proteomic changes associated with the development of graft versus host disease (GvHD). II. For clinical efficacy, \> 50% of subjects with at least 1 stage of gut GvHD improvement by 8 weeks after the first dose of FMT. OUTLINE: Patients ingest OpenBiome FMT Capsule Dose Extended (DE) orally for two consecutive days. One dose is equivalent to the ingestion of 30 capsules and thus each day the patient will ingest 15 capsules. If no response is noted after 7 days, patients may receive a second dose of FMT for an additional 2 days. Standard treatment for gut GvHD will continue during this time. After completion of study treatment, patients are followed for up to 6 months.

Conditions

• Acute Graft Versus Host Disease
• Gastrointestinal Tract Acute Graft Versus Host Disease
• Severe Gastrointestinal Tract Acute Graft Versus Host Disease
• Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation Capsule	Receive OpenBiome FMT Capsule DE PO

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-30
• Completion: 2025-12-01
• First posted: 2020-02-21
• Last updated: 2023-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study