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FECES – Fecal microbiota transplantation to eradicate colonizing multidrug-resistant gram-negative bacteria
2024-516393-29-00Phase 3Authorised
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Start
- Dec 2024
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in Intestinal colonization with multidrug-resistant Gram-negative bacteria, Gastrointestinal colonization with carbapenem-resistant Enterobacteriaceae and Intestinal colonization with extended-spectrum beta-lactamase-producing Enterobacteriaceae comparing Allogeneic pooled fecal microbiota capsules with Placebo fecal microbiota capsules (2 arms). Primary endpoint: Proportion of subjects not carrying MDR-GNB at 30 ± 10 days. Planned start Dec 2024; status: authorised.
02
Drugs
allogeneic pooled fecal microbiota
03
Conditions
Intestinal colonization with multidrug-resistant Gram-negative bacteriaGastrointestinal colonization with carbapenem-resistant EnterobacteriaceaeIntestinal colonization with extended-spectrum beta-lactamase-producing Enterobacteriaceae
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