Study of Alanyl-glutamine with Standard Treatment to Reduce Recurrence and Death in Adults with C. difficile Infection

What this Trial Is About

Researchers are evaluating the use of oral alanyl-glutamine AQ supplementation alongside standard therapy to treat Clostridioides difficile infection CDI in adults aged 18 and older. This Phase II, randomized, double-blind, placebo-controlled trial aims to determine the optimal dose and safety of AQ given in doses of 0, 4, 24, or 44 grams daily for 10 days. The study hypothesizes that AQ may reduce CDI recurrence and mortality while improving inflammatory markers and intestinal microbiota function. Participants are randomly assigned to one of four groups receiving AQ at 4, 24, or 44 grams or a placebo, administered once daily orally or through a feeding tube if needed. The treatment lasts 10 days and is given alongside standard antibiotics such as oral vancomycin or fidaxomicin. The trial uses block randomization to maintain balance over the enrollment period and follows participants daily during treatment and weekly for 60 days afterward to monitor for recurrence and survival. During the study, researchers collect blood, urine, and stool samples at the start, after 10 days, and at 70 days to analyze inflammation and microbial changes. Participants may attend in-person or virtual visits, with options for sample shipment if needed. Safety is closely monitored throughout treatment and follow-up. The main outcome measured is the number of participants with recurrent CDI within 60 days post-treatment, with mortality as a secondary outcome. The total participation period covers treatment and 60 days of follow-up.

Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)