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Fecal microbiota transplant (FMT) is an investigational biological treatment being studied for pediatric patients (ages 3-21) with recurrent or moderate to severe Clostridioides difficile infection, both with and without inflammatory bowel disease. This therapeutic approach involves transplanting the complete fecal microbiota from healthy, screened donors into the patient's gastrointestinal tract. The primary mechanism of action is the restoration of a healthy and diverse gut microbiome, which enhances colonization resistance against pathogenic bacteria like C. difficile. A Phase 1 clinical trial (NCT02636517) led by Dr. Judith Kelsen at the Children's Hospital of Philadelphia is evaluating the safety and efficacy of this modality, and characterizing the changes in the gut microbiome before and after transplantation.
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