Status:
RECRUITING
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Carilion Clinic
University of Southampton
Conditions:
Clostridioides Difficile Infection
Clostridium Difficile Infection
Eligibility:
All Genders
18-105 years
Phase:
PHASE2
Brief 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 ther...
Detailed Description
This is a Phase II randomized, placebo-controlled, double-blinded, dose-ranging study to determine optimal effective dose and safety of AQ between 0, 4, 24, and 44 g doses administered orally for ten ...
Eligibility Criteria
Inclusion
- 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.
- Presence of diarrhea\*
- Episode of C. difficile infection, non-severe or severe uncomplicated.
- Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin).
- 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
- At enrollment, presence of any of the following:
- Hypotension or shock
- Megacolon or moderate to severe ileus
- Acute abdomen
- Admission to intensive care unit
- Inability to tolerate oral or enteral medication
- Presence of other known infectious etiology of diarrhea
- COVID-19 co-infection at the time of CDI diagnosis.
- Absolute neutrophil count \<500 mcl
- 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).
- Enrollment in another investigational drug trial
- Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).
- On probiotics and not willing to discontinue.
- Cirrhosis or in participants with ALT \> 3X normal
- End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \<30mL/min even after adequate hydration
- Life expectancy of \< 6 months.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04305769
Start Date
June 1 2021
End Date
June 30 2027
Last Update
October 26 2024
Active Locations (2)
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1
UVA Health Systems
Charlottesville, Virginia, United States, 22903
2
Carilion Clinic
Roanoke, Virginia, United States, 24014