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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04305769
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Not accepted

Interventions

  • Alanyl-glutamine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Alanyl-glutamine 0g
  • Experimental: Alanyl-glutamine 4g
  • Experimental: Alanyl-glutamine 24g
  • Experimental: Alanyl-glutamine 44g

Primary Outcome Measure

Number of participants with recurrent CDI. [ Time Frame: Within 60 days post-treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
UVA Health SystemsCharlottesvilleVirginia22903
Cirle Warren, M.D.
[email protected]
434-270-1082
Darren Hackley, M.A., CCRP
[email protected]
540-613-2972
Cirle Warren, M.D.
Carilion ClinicRoanokeVirginia24014
Ekta Bansal, M.D.
[email protected]
540-200-9065
Ruth Ndolo, Ed.D, RN, CCRP
[email protected]
540-266-6557
Ekta Bansal, M.D.
Jazmine Jackson-Akers, D.O.

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