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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Clostridioides Difficile Infection
Intervention / Treatment

-

Contacts and Locations

Charlottesville

UVA Health Systems, Charlottesville, Virginia, United States, 22903

Roanoke

Carilion Clinic, Roanoke, Virginia, United States, 24014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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
  • 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.

Ages Eligible for Study

18 Years to 105 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

Study Record Dates

2027-06-30