Trial intelligence / Profile preview

Alanyl-glutamine Supplementation for C. Difficile Infection

NCT02053350Phase 2

Key facts

Status
Terminated
Start
Apr 2015
Primary completion
Apr 2017
Countries
1
Sponsor
University of Virginia
Modality
Peptides, Recombinant Proteins and Enzymes, Small Molecules
Conditions
Clostridioides difficile infection (CDI)
01

Overview

Phase 2, randomised, double-blind trial of alanyl glutamine in Clostridioides difficile infection (CDI), sponsored by University of Virginia. Primary endpoints: Number of Participants With Recurrent C. Difficile Infection at 40 days and Mortality at 6 months. Started Apr 2015; status: terminated.

02

Design

Study design
RandomizedDouble-blind
03

Who it enrols

Adults 18+ (or 50+ per detailed description) with first-time uncomplicated C. difficile infection, hospitalized, receiving standard antibiotics (metronidazole or vancomycin). Excludes severe disease (WBC > 20k, ICU, shock), chronic liver/kidney disease, and other causes of diarrhea.

04

Endpoints

Primary

  • Number of Participants With Recurrent C. Difficile Infection

  • Mortality

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