Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised...

Area of Science:

• Gastroenterology
• Infectious Diseases
• Clinical Pharmacology

Background:

• Clostridioides difficile infection (CDI) is a major cause of hospital-acquired infections, with significant healthcare costs and high recurrence rates.
• Existing treatments for CDI have limitations, particularly concerning recurrent infections.
• Alanyl-glutamine (AQ) shows potential in preliminary studies for improving intestinal barrier function and reducing inflammation associated with CDI.

Purpose of the Study:

• To evaluate the optimal dosage and safety of oral alanyl-glutamine (AQ) in patients with CDI.
• To determine the efficacy of AQ in reducing CDI recurrence compared to placebo.
• To explore the impact of AQ on intestinal and systemic inflammation, and gut microbiome.

Main Methods:

• A randomized, placebo-controlled, double-blind, phase II clinical trial.
• Participants aged 18 or older with non-severe or severe uncomplicated CDI received standard treatment plus oral AQ (4, 24, or 44 g daily for 10 days) or placebo.
• Primary outcome: CDI recurrence within 60 days post-treatment. Secondary outcome: mortality within 60 days.

Main Results:

• This section is to be filled once the study results are available.
• The study is designed to collect data on CDI recurrence, mortality, and inflammatory markers.
• Exploratory analyses will investigate changes in intestinal and systemic inflammation, and microbial/metabolic profiles.

Conclusions:

• This section is to be filled once the study results are available.
• The findings will inform the potential use of alanyl-glutamine as an adjunct therapy for CDI.
• Further research will be guided by the safety and efficacy data from this phase II trial.