ALANYL-GLUTAMINE FOR CDI TREATMENT (ACT)
Alanyl-glutamine supplementation of standard treatment for C. difficile infection: A randomized, double-blind, placebo-controlled trial
About
Clostridium difficile infection (CDI) is the most common cause of healthcare-associated infection and antibiotic-associated diarrhea. Anti-CDI antibiotics are effective for initial infection, and thus remain as the standard of care in human infection.
However, recurrent disease occurs in up to 25% of initial infection and up to more than 60% of succeeding infections. Novel, affordable, accessible approaches to treatment that prevent recurrent CDI and improve survival, especially among older adults, are urgently needed. Strategies to prevent the first episode of recurrence are critical to stop the vicious cycle of more antibiotic use in this antibiotic-induced disease.
This study will examine the effectiveness and safety of Alanyl-glutamine addition to the standard treatment for CDI in preventing relapse or re-infection. Alanyl-glutamine consists of two amino acids: L-alanyl and L- glutamine. Furthermore, the investigators hypothesize that Alanyl-glutamine supplementation will be associated with decreased intestinal and systemic inflammation.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged >18 years
- Admitted in the hospital
- Presence of diarrhea*
- Stool positive for C. difficile
Exclusion Criteria
At enrollment, presence of any of the following:
- Hypotension or shock
- Megacolon or moderate to severe ileus
- Acute abdomen
- Admission to intensive care unit
- Inability to tolerate oral or enteral medication
- Presence of other known infectious etiology of diarrhea
- COVID-19 co-infection at the time of CDI diagnosis
- Absolute neutrophil count <500 mcl
Primary Investigator
Ekta Bansal, M.D., is an Infectious Diseases physician with over 11 years of clinical experience. She is an associate professor at the Virginia Tech Carilion School of Medicine and is board certified by American Board of Internal Medicine (Infectious Disease). She completed her fellowship at Carilion Clinic; her internship at Government Medical College & Hospital, Chandigarh, India; and her residency at Mercy Catholic Medical Center.
Contact Information
Ruth Ndolo, R.N.
Clinical Research Nurse
