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

• Status: Terminated
• Trial end date: 2017-04-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Glycine

Criteria

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