Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Trial Parameters
Brief 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.
Eligibility Criteria
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 provide consent, in person or remotely via virtual or electronic means. Exclusion Criteria: 1. At enrollment, presence of any of the following: 1. Hypotension or shock 2. Megacolon or moderate to severe ileus 3. Acute abdomen 4. Admission to intensive care unit 2. Inability to tolerate oral or enteral medication 3. Presence of other known infectious etiology of diarrhea 4. COVID-19 co-infection at t