Actively Recruiting
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Led by University of Virginia · Updated on 2024-10-26
260
Participants Needed
2
Research Sites
317 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
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.
CONDITIONS
Official Title
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female, aged 18 years and 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 with oral vancomycin or fidaxomicin
- Able to provide informed consent in person or electronically, or via legally authorized representative in person or remotely
You will not qualify if you...
- Presence of hypotension or shock at enrollment
- Presence of megacolon or moderate to severe ileus
- Acute abdomen at enrollment
- Admission to intensive care unit
- Inability to tolerate oral or enteral medication
- Other known infectious cause of diarrhea
- COVID-19 co-infection at time of CDI diagnosis
- Absolute neutrophil count below 500 per microliter
- Within 100 days of hematologic or solid organ transplant
- Inflammatory bowel disease or other non-infectious diarrhea unless well-controlled and stable
- Enrollment in another investigational drug trial
- Current use of alternative CDI treatments other than vancomycin or fidaxomicin
- Using probiotics and unwilling to discontinue
- Cirrhosis or ALT levels greater than three times normal
- End stage renal disease unless on dialysis or with low kidney function despite hydration
- Life expectancy less than 6 months
AI-Screening
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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
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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