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RECRUITING
NCT04305769
PHASE2

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. The investigators hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.

Official title: Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial

Key Details

Gender

All

Age Range

18 Years - 105 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2021-06-01

Completion Date

2027-06-30

Last Updated

2024-10-26

Healthy Volunteers

No

Interventions

DRUG

Alanyl-glutamine

The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.

Locations (2)

UVA Health Systems

Charlottesville, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States