Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
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 persons aged 65 or older. Our 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.
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 > 65 years

 4. Admitted in the hospital

 5. Presence of diarrhea*

 6. Stool positive for C. difficile tcdB and TcdB

 7. 1st episode of C. difficile infection, non-severe or severe uncomplicated

 8. Within 48 hours of receiving standard therapy (oral vancomycin at UVA)

 Exclusion Criteria:

 1. At enrollment, presence of any of the following:

 -  Hypotension or shock

 -  Megacolon or moderate to severe ileus

 -  Acute abdomen

 -  Admission to intensive care unit

 2. Inability to tolerate oral or enteral medication

 3. Presence of other known infectious etiology of diarrhea

 4. Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other
 etiology of non-infectious diarrhea

 5. Enrollment in another investigational drug trial

 6. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin
 or fidaxomicin; IVIg; fecal transplant).

 7. On probiotics and not willing to discontinue.

 8. Cirrhosis or in participants with ALT > 3X normal

 9. End stage renal disease, on dialysis, or creatinine clearance or estimated GFR of
 <30mL/min even after adequate hydration

 10. Life expectancy of < 6 months.