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

This study is testing alanyl-glutamine, a supplement, alongside standard treatment for Clostridioides difficile infection (CDI). CDI is a bacterial infection that causes diarrhea and inflammation of the colon. Researchers want to find the best dose of alanyl-glutamine to reduce how often CDI comes back and to improve patient outcomes. You might be able to join if you are 18 or older, have CDI, and are being treated at UVA or Carilion hospitals, or as an outpatient at UVA. The study will look at whether alanyl-glutamine helps prevent CDI from returning within 60 days after treatment.

Study design
This is a Phase II, randomized, double-blind, placebo-controlled study with 260 participants. Participants will be divided into four groups, receiving different doses of alanyl-glutamine or a placebo.
What's involved
You would take alanyl-glutamine or a placebo orally once a day for 10 days. You will have daily check-ups during treatment and weekly check-ups for 60 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed weekly for 60 days after treatment to check for recurrences and survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04305769

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Virginia
~260 participants
Updated 2024-10-26 on ClinicalTrials.gov
What's tested:Alanyl-glutamine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with recurrent CDI.
Measured over Within 60 days post-treatment
Clostridioides Difficile Infection
Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Clostridia Difficile Colitis
2 sites across 1 states
Virginia2

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  • Number of participants with recurrent CDI.Within 60 days post-treatment

    Documented C difficile infection defined by presence of recurrent diarrhea with stool positive for C difficile assay necessitating treatment with anti-C. difficile antibiotic.