A Randomized Controlled Trial of Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

NCT02269150 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	59
Start date	2014-10
Completion	2026-10

Conditions

• Allogeneic Hematopoietic Stem Cell

Interventions

• fecal microbiota transplantation (FMT)
• No fecal microbiota transplantation (FMT), routine management

Primary outcomes

• Clostridium difficile infection (CDI) — up to 1 year following randomization
  CDI is defined as diarrheal stool (unformed stool conforming to the shape of a specimen container), and a positive test for toxin-producing C. difficile (either by toxin B gene PCR or cytotoxicity assay).

Countries

United States