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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-105
SponsorUniversity of Virginia

About this trial

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 criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18 years and older.

Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital.

Disqualifiers

Hypotension or shock

Megacolon or moderate to severe ileus

Acute abdomen

Admission to intensive care unit

Trial design

Treatments tested in this trial

  • Alanyl-glutamine

Treatment groups

260 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Virginia

Lead sponsor

Carilion Clinic

Collaborator

University of Southampton

Collaborator