Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
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. Our 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
🗓️ Study Start (Actual) 1 June 2021
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 260
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Charlottesville, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Provision of signed and dated informed consent form
    • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
    • 3. Male or female, aged 18 years and older.
    • 4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carrilion hospital.
    • 5. Presence of diarrhea\*
    • 6. Episode of C. difficile infection, non-severe or severe uncomplicated.
    • 7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin).
    • 8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means.

    Exclusion Criteria:

    • 1. At enrollment, presence of any of the following:
    • 1. Hypotension or shock
    • 2. Megacolon or moderate to severe ileus
    • 3. Acute abdomen
    • 4. Admission to intensive care unit
    • 2. Inability to tolerate oral or enteral medication
    • 3. Presence of other known infectious etiology of diarrhea
    • 4. COVID-19 co-infection at the time of CDI diagnosis.
    • 5. Absolute neutrophil count \<500 mcl
    • 6. Within 100 days of hematologic or solid organ transplant
    • • Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea. For patients with history of IBD, allow enrollment if disease is well-controlled and stable (not in flare).
    • 7. Enrollment in another investigational drug trial
    • 8. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).
    • 9. On probiotics and not willing to discontinue.
    • 10. Cirrhosis or in participants with ALT \> 3X normal
    • 11. End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \<30mL/min even after adequate hydration
    • 12. Life expectancy of \< 6 months.
Ages Eligible for Study: 18 Years to 105 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 March 2020
  • First Submitted that Met QC Criteria 9 March 2020
  • First Posted 12 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2023
  • Last Update Posted 11 July 2023
  • Last Verified July 2023