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

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.

Timeline

Start

2021-06-01

Primary completion

2026-12-31

Completion

2027-06-30

Publications

• Warren CA, Shin JH, Bansal EN, Costa DVDS, Wang XQ, Wu M, Swann JR, Behm BW, Targonski PV, Archbald-Pannone L. Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol. BMJ Open. 2023 Jul 19;13(7):e075721. doi: 10.1136/bmjopen-2023-075721.

Drugs

Indications