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New treatment option for Clostridioides Difficile Infection
Official title Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
ClinicalTrials.gov ID: NCT04305769
What this study is testing
What is Alanyl-glutamine?
Alanyl-glutamine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for clostridioides difficile infection.
Also referred to as Alagln, AQ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 105
You may be able to join if
- 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\
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
- Roanoke, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 105 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States; Roanoke, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.