Recruiting
Phase 2

Alanyl-Glutamine

Sponsor:

University of Virginia

Code:

NCT04305769

Conditions

Clostridioides Difficile Infection

Clostridium Difficile Infection

Clostridium Difficile Diarrhea

Clostridia Difficile Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Alanyl-glutamine

Study Details

Brief 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.

Conditions

Clostridioides Difficile Infection

Clostridium Difficile Infection

Clostridium Difficile Diarrhea

Clostridia Difficile Colitis

Study ID

NCT04305769

Start date

Jun 1, 2021

Status verified date

Oct, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Alanyl-glutamine 0g

experimental: Alanyl-glutamine 4g

experimental: Alanyl-glutamine 24g

experimental: Alanyl-glutamine 44g

Interventions

Alanyl-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.

Primary outcome measure

  • Number of participants with recurrent CDI. [ Time Frame: Within 60 days post-treatment ]

Central Contacts and Locations

Locations

UVA Health Systems

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Oct 26, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.