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Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Sponsor: University of Virginia
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
Conditions
Interventions
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