Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial
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.
Description
This is a Phase II randomized, placebo-controlled, double-blinded, dose-ranging study to determine optimal effective dose and safety of AQ between 0, 4, 24, and 44 g doses administered orally for ten days concurrent with standard treatment (oral vancomycin or fidaxomicin at UVa) among cases of CDI in hospitalized persons, persons who are referred to the UVA C. difficile clinic or Carilion Hospital, age 18 and older. The investigators hypothesis is that AQ will reduce recurrence (primary outcome) and mortality (secondary outcome) at 60 days post-treatment. Furthermore, the investigators hypothe…
Eligibility
- Age range
- 18–105 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years and older. 4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital. 5. Presence of diarrhea\* 6. Episode of C. difficile infection, non-severe or severe uncomplicated. 7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin). 8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to p…
Interventions
- DrugAlanyl-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 SystemsCharlottesville, Virginia
- Carilion ClinicRoanoke, Virginia