Clinical Trial Testing Fecal Microbiota Transplant for Recurrent Diarrheal Disease Begins

Digitally-colorized scanning electron microscopic (SEM) image depicts a large grouping of rod-shaped, Gram-positive Clostridium difficile bacteria.

The NIAID-supported Vaccine and Treatment Evaluation Units (VTEUs) recently began enrolling patients in a clinical trial examining whether fecal microbiota transplantation by enema—putting stool from a healthy donor in the colon of a recipient—is safe and can prevent recurrent Clostridium difficile-associated disease (CDAD), a potentially life-threatening diarrheal illness.

Although more research is needed to determine precisely how FMT effectively cures recurrent CDAD, the treatment appears to rapidly restore a healthy and diverse gut microbiome in recipients. Physicians perform FMT using various routes of administration, including oral pills, upper gastrointestinal endoscopy, colonoscopy, and enema. The new NIAID-supported trial aims to investigate the safety and efficacy of FMT delivered by enema to patients with recurrent CDAD. The trial is part of an effort to gather data on how best to standardize the FMT process.