Efficacy Study of Alanyl-glutamine Supplementation for the Treatment of C. Difficile Infection

Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:18 - Any
Start Date:April 2015
End Date:October 2016
Contact:Ashley Chaplin, M.D.

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Alanyl-glutamine Supplementation of Standard Treatment of C. Difficile Infection: A Randomized, Double-blind, Placebo-controlled Trial

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

- 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
We found this trial at
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Cirle A. Warren, M.D.
Phone: 434-924-9676
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
Charlottesville, VA
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