# Alanyl-glutamine supplementation of standard treatment for C. difficile infection

> **NIH NIH R01** · UNIVERSITY OF VIRGINIA · 2022 · $805,350

## Abstract

PROJECT SUMMARY
C. difficile is the leading cause of antibiotic-associated diarrhea and nosocomial infection. Antibiotic treatment is
the standard approach in managing C. difficile infection (CDI) and is associated with high recurrence rates of up
to 65% depending on the number of previous disease. Alanyl-glutamine prevents C. difficile toxin-induced
impairment of cell migration and proliferation in intestinal cell lines, secretion and histopathology in animal ileal
tissues, and increased apoptosis in vitro and in vivo. We have shown that in the mouse model of CDI, alanyl-
glutamine supplementation significantly reduced diarrhea, weight loss, histopathology, relapse and deaths in
vancomycin-treated mice. A small pilot study in human suggests that alanyl-glutamine may prevent recurrent
disease up to 6 months after CDI treatment. We hypothesize that supplementation with alanyl-glutamine will
improve outcomes of treatment of CDI in humans. To prove this hypothesis, we plan to conduct a
randomized, double-blinded, placebo-controlled trial. The specific aims of this project are 3-fold. First, we shall
determine the optimal dose of oral alanyl-glutamine on preventing recurrence and deaths in patients
treated with standard anti-C.difficile agents. Secondly, we shall demonstrate the safety of oral alanyl-
glutamine supplementation. And thirdly, we shall test the effect of alanyl-glutamine on intestinal
inflammation, barrier function and gut flora in patients undergoing standard treatment for CDI. This
research proposal will allow for a rigorous, safe and productive performance of the clinical trial to prove the
benefit of alanyl-glutamine in human disease, potentially introducing a novel approach to treatment of CDI.

## Key facts

- **NIH application ID:** 10443734
- **Project number:** 5R01AI145322-03
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Cirle Alcantara Warren
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $805,350
- **Award type:** 5
- **Project period:** 2020-07-13 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10443734

## Citation

> US National Institutes of Health, RePORTER application 10443734, Alanyl-glutamine supplementation of standard treatment for C. difficile infection (5R01AI145322-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10443734. Licensed CC0.

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