Trial intelligence / Profile preview

Fecal transplant to eradicate colonization with extensively drug-resistant bacteria

2014-003048-11Phase 4Active

Sponsor
GIPIT
Start
Jun 2015
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
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Overview

Phase 4, open-label, single-arm trial of allogeneic fecal microbiota in Gastrointestinal colonization with extensively drug-resistant bacteria (XDR-GIC), Glycopeptide-resistant enterococci colonization and Carbapenem-resistant Enterobacteriaceae colonization, sponsored by GIPIT. Primary endpoint: Negativation of rectal swab. Started Jun 2015; status: active.

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Drugs

allogeneic fecal microbiota
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Conditions

Gastrointestinal colonization with extensively drug-resistant bacteria (XDR-GIC)Glycopeptide-resistant enterococci colonizationCarbapenem-resistant Enterobacteriaceae colonization

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