Drug intelligence / Profile preview

fecal microbiota transplant (Judith Kelsen)

Development stage
Unknown
Lead developer
Judith Kelsen
Modality
Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Rectal
01

Overview

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.

Other names
FMTfecal transplantfecal bacteriotherapystool transplantintestinal microbiota transplant

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