ACT

Summary

The bacterium Clostridium difficile is the most common cause of healthcare-associated infections and antibiotic-associated diarrhea. This organism is spread easily among people, and cases of C difficile infection (CDI) have increased in the past decade. In addition, CDI can be fatal, with approximately 90% of CDI-associated deaths in elderly persons. Antibiotics remain effective for initial episodes of CDI and thus are the standard of care in these cases. However, 25% of first-time CDI patients develop repeat infections, and more than 60% of patients with repeat CDI will continue to have additional bouts. New treatments that prevent recurrent CDI and improve survival are urgently needed. 

The amino acid glutamine is an important energy source in the body, particularly for intestinal cells. Glutamine and glutamine dipeptides (e.g., alanyl-glutamine [AQ]) enhance gut repair mechanisms, decrease intestinal inflammation, and reduce bacterial spread from the GI tract. For these reasons, AQ may be useful for treating CDI. In addition, AQ may support the growth of beneficial gut bacteria, thus preventing relapses of CDI. 

ACT asks whether adding AQ to standard therapy decreases gut inflammation, gastrointestinal symptoms, and recurrent or fatal disease among adults with diarrhea due to CDI. Study participants will be assigned randomly (50:50, like a coin toss) to receive standard treatment for CDI with or without the addition of AQ. Neither the lead scientist nor participants can choose or will know which treatment they receive. Blood, urine, and stool specimens are collected from participants a total of 3 times during the 70-day participation window. 

To be included in ACT, participants must be / have

• Adult (18 years and older) 
• In the hospital 
• Currently experiencing diarrhea 
• Stool positive for C. difficile 

To be included in ACT, participants must not be / have 

• In the intensive care unit 
• Low blood pressure or shock 
• Megacolon or moderate to severe ileus 
• Diarrhea due to an infectious agent other than C. difficile 
• Active COVID-19 infection at the time of CDI diagnosis 

Keywords
C difficile; Gastrointestinal infection