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Alanyl-glutamine for CDI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305769
Recruitment Status : Not yet recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Cirle Warren, MD, University of Virginia

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 persons aged 65 or older. Our 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.

Condition or disease Intervention/treatment Phase
Clostridioides Difficile Infection Clostridium Difficile Infection Clostridium Difficile Diarrhea Clostridia Difficile Colitis Drug: Alanyl-glutamine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomization will be applied to assign participants to one of the four study groups, either one of the three experimental (AQ) or control (placebo) group in 1:1:1:1 allocation from a list containing the randomized and blinded treatment assignments.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: A Randomized, Double-blind, Placebo-controlled Trial
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Placebo Comparator: Alanyl-glutamine 0g Drug: 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.
Other Names:
  • Alagln
  • AQ
  • glutamine

Experimental: Alanyl-glutamine 4g Drug: 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.
Other Names:
  • Alagln
  • AQ
  • glutamine

Experimental: Alanyl-glutamine 24g Drug: 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.
Other Names:
  • Alagln
  • AQ
  • glutamine

Experimental: Alanyl-glutamine 44g Drug: 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.
Other Names:
  • Alagln
  • AQ
  • glutamine




Primary Outcome Measures :
  1. Recurrent C. difficile infection [ Time Frame: Within 60 days post-treatment ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Within 60 days post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 65 years
  4. Admitted in the hospital
  5. Presence of diarrhea*
  6. Stool positive for C. difficile tcdB and TcdB
  7. 1st episode of C. difficile infection, non-severe or severe uncomplicated
  8. Within 48 hours of receiving standard therapy (oral vancomycin at UVA)

Exclusion Criteria:

  1. At enrollment, presence of any of the following:

    • Hypotension or shock
    • Megacolon or moderate to severe ileus
    • Acute abdomen
    • Admission to intensive care unit
  2. Inability to tolerate oral or enteral medication
  3. Presence of other known infectious etiology of diarrhea
  4. Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea
  5. Enrollment in another investigational drug trial
  6. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).
  7. On probiotics and not willing to discontinue.
  8. Cirrhosis or in participants with ALT > 3X normal
  9. End stage renal disease, on dialysis, or creatinine clearance or estimated GFR of <30mL/min even after adequate hydration
  10. Life expectancy of < 6 months.

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Responsible Party: Cirle Warren, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04305769    
Other Study ID Numbers: 200046
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections