Clinical Trial

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

Study acronym: ACT
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-03-09; most recent amendment 2024-10-22.
Status change: Not Yet Recruiting → Recruiting 2021-04-30
Trial Details
NCT Number NCT04305769
Lead Sponsor University of Virginia
Collaborators: Carilion Clinic, University of Southampton
Conditions Clostridioides Difficile Infection, Clostridium Difficile Infection, Clostridium Difficile Diarrhea, Clostridia Difficile Colitis
Enrollment 260 participants
Start Date 2021-06-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-26