RecruitingPhase 2NCT04305769

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

Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial

Sponsor

University of Virginia

Enrollment

260 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Clostridium Difficile Infection Clostridioides Difficile Infection Clostridium Difficile Diarrhea Clostridia Difficile Colitis

Summary

This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. The investigators hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.

Eligibility

Min Age: 18 YearsMax Age: 105 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Alanyl-glutamine for people with clostridia difficile colitis, clostridioides difficile infection, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 105 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAlanyl-glutamine

The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.