About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 years and older.
Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital.
Disqualifiers
Hypotension or shock
Megacolon or moderate to severe ileus
Acute abdomen
Admission to intensive care unit
Trial design
Treatments tested in this trial
- Alanyl-glutamine