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

NCT04305769 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-10-26

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Alanyl-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.

Sponsors & Collaborators

  • Carilion Clinic

    collaborator OTHER

  • University of Southampton

    collaborator OTHER

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305769 on ClinicalTrials.gov