Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)

Launched by UNIVERSITY OF VIRGINIA · Mar 9, 2020

Keywords

ClinConnect Summary

The Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) trial is studying whether a supplement called alanyl-glutamine can help patients who have a C. difficile infection (CDI), a type of bacterial infection that causes diarrhea and can be serious. The trial will test different doses of this supplement over 10 days alongside standard treatment to see if it reduces the chances of the infection coming back or leading to serious complications. Researchers hope that taking this supplement might improve the gut's health and help the body fight off the infection better.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with a non-severe or severe C. difficile infection. They should also be admitted to the hospital or seen as an outpatient within a few days of starting standard treatment. Those interested in participating will need to provide consent and may need to meet specific criteria, such as not having certain severe health conditions at the time of enrollment. Participants can expect to take the supplement in addition to their usual treatment and will be monitored throughout the study. It's important to note that people currently receiving other treatments for CDI or with specific health issues may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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 Carilion 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.