Using alanyl-glutamine to treat C. difficile infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II trial investigates the effectiveness and safety of oral alanyl-glutamine supplementation in patients with uncomplicated C. difficile infections. Participants will be randomly assigned to receive either alanyl-glutamine at varying doses or a placebo for ten days, alongside standard treatment with oral vancomycin or fidaxomicin. The study aims to assess the impact of alanyl-glutamine on recurrence and mortality rates, as well as its effects on inflammatory markers and intestinal microbiota. A total of 260 patients will be enrolled and monitored for 60 days post-treatment to evaluate outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• UVA Health Systems
  Charlottesville, Virginia, United States Recruiting
• Carilion Clinic
  Roanoke, Virginia, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.