Efficacy Study of Alanyl-glutamine Supplementation for the Treatment of C. Difficile Infection
Efficacy Study of Alanyl-glutamine Supplementation for the Treatment of C. Difficile Infection
The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the
 treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with
 standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality
 and recurrent disease.
Inclusion Criteria:

 -  Adult of either gender, 18 years or older, with C. difficile infection (CDI)

 -  Diarrhea associated with C. difficile positive stool assay

 -  Within 48 hours of receiving either metronidazole for mild-moderate disease or
 vancomycin for severe uncomplicated disease

 -  Admitted in the hospital at the time of enrollment

 -  Ability to provide informed consent

 -  Have an understanding of study procedures

 -  Ability to comply with study procedures for the entire length of the study

 Exclusion Criteria:

 -  Hypotension or shock

 -  Megacolon or moderate to severe ileus

 -  Acute abdomen

 -  Severe leukocytosis (WBC > 20,000 cells /µL)

 -  Admission to intensive care unit on enrollment

 -  Inability to tolerate oral medication

 -  Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal
 disease)

 -  Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)

 -  Enrollment in another investigational drug trial

 -  Currently receiving other alternative treatment for CDI (e.g. antibiotics other than
 metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)

 -  Pregnancy

 -  Unavailable for follow-up visits

 -  Life expectancy of < 6 months

 -  Chronic liver disease or in subjects without known liver disease, ALT > 3x normal

 -  Chronic kidney disease or in subjects without known kidney disease, estimated
 Creatinine clearance of < 30 ml/min, even after rehydration