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fecal microbiota transplantation (Montefiore Medical Center)

Development stage: Discontinued
Lead developer: Montefiore Medical Center
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: Oral

Overview

An investigational biologic therapy consisting of oral capsules containing fecal microbiota from healthy donors, provided by OpenBiome. This fecal microbiota transplantation (FMT) therapy was studied for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D). The therapy aims to restore a healthy intestinal microbiome. A multicenter, randomized, double-blind, placebo-controlled crossover trial (NCT02328547) led by Dr. Olga C. Aroniadis at Montefiore Medical Center was conducted to evaluate its efficacy and safety. The trial was terminated early after an interim analysis showed that the FMT capsules did not provide significantly greater symptom relief than placebo at 12 weeks, though the treatment was found to be safe.

Other names: fecal microbiota transplantation-Montefiore Medical Center-irritable bowel syndrome (diarrhea-predominant)FMT capsules (OpenBiome)

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