RecruitingPhase 2NCT04305769

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

Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial

Sponsor

University of Virginia

Enrollment

260 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Clostridium Difficile Infection Clostridioides Difficile Infection Clostridium Difficile Diarrhea Clostridia Difficile Colitis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 105 Years

Inclusion Criteria8

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.

Exclusion Criteria17

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 flare).
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.

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Interventions

DRUGAlanyl-glutamine

The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.