Alanyl-glutamine supplementation for Clostridioides difficile infection treatment (ACT): a double-blind randomised controlled trial study protocol.
Cirle A Warren, Jae Hyun Shin, Ekta N Bansal...
https://pubmed.ncbi.nlm.nih.gov/37474181Actively Recruiting
Phase 2
Age: 18Years - 105Years
All Genders
ID04305769
Alanyl-glutamine Supplementation of Standard Treatment for Clostridioides difficile Infection: A Randomized, Double-blind, Placebo-controlled Trial
Led by University of Virginia · Updated on 2024-10-26
260
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
C
Carilion Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of oral alanyl-glutamine (AQ) supplementation alongside standard therapy to treat Clostridioides difficile infection (CDI) in adults aged 18 and older. This Phase II, randomized, double-blind, placebo-controlled trial aims to determine the optimal dose and safety of AQ given in doses of 0, 4, 24, or 44 grams daily for 10 days. The study hypothesizes that AQ may reduce CDI recurrence and mortality while improving inflammatory markers and intestinal microbiota function. Participants are randomly assigned to one of four groups receiving AQ at 4, 24, or 44 grams or a placebo, administered once daily orally or through a feeding tube if needed. The treatment lasts 10 days and is given alongside standard antibiotics such as oral vancomycin or fidaxomicin. The trial uses block randomization to maintain balance over the enrollment period and follows participants daily during treatment and weekly for 60 days afterward to monitor for recurrence and survival. During the study, researchers collect blood, urine, and stool samples at the start, after 10 days, and at 70 days to analyze inflammation and microbial changes. Participants may attend in-person or virtual visits, with options for sample shipment if needed. Safety is closely monitored throughout treatment and follow-up. The main outcome measured is the number of participants with recurrent CDI within 60 days post-treatment, with mortality as a secondary outcome. The total participation period covers treatment and 60 days of follow-up.
CONDITIONS
Brief Title
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Who Can Participate
Age: 18Years - 105Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with study procedures and availability for the study duration
- Male or female aged 18 years or older
- Admitted to UVA hospital, seen as outpatient, or seen at Carilion hospital
- Presence of diarrhea
- Episode of non-severe or severe uncomplicated C. difficile infection
- Within 120 hours of starting standard therapy (oral vancomycin or fidaxomicin)
- Able to provide informed consent in person or electronically, or have a legally authorized representative provide consent
You will not qualify if you...
- Presence of hypotension or shock at enrollment
- Presence of megacolon or moderate to severe ileus
- Presence of acute abdomen
- Admission to intensive care unit
- Unable to tolerate oral or enteral medication
- Other known infectious cause of diarrhea
- COVID-19 co-infection at CDI diagnosis
- Absolute neutrophil count below 500/mcL
- Within 100 days of hematologic or solid organ transplant
- Inflammatory bowel disease unless well-controlled and stable
- Enrollment in another investigational drug trial
- Current use of alternative CDI treatments (e.g., antibiotics other than vancomycin or fidaxomicin, IVIg, fecal transplant)
- On probiotics and unwilling to discontinue
- Cirrhosis or ALT greater than 3 times normal
- End stage renal disease unless on dialysis or with creatinine clearance below 30 mL/min after hydration
- Life expectancy less than 6 months
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Treatment
Duration - 10 days
Participants receive daily oral or enteral supplementation with alanyl-glutamine or placebo along with standard treatment for Clostridioides difficile infection.
Daily visits for adverse event monitoring during treatment
Follow-up
Duration - 60 days post-treatment
Participants are followed weekly for up to 60 days post-treatment to monitor for recurrence of infection and survival.
Weekly visits for up to 60 days post-treatment
Trial Site Locations
Total: 2 locations
1
UVA Health Systems
Charlottesville, Virginia, United States, 22903
Actively Recruiting
2
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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