Status:
WITHDRAWN
Glutamine Supplementation in People With Immune Dysregulation
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Eczema
MTOROC1 Signaling
Eligibility:
All Genders
5-65 years
Phase:
EARLY_PHASE1
Brief Summary
Background: Glutamine is an amino acid. People get amino acids from food or from the body s cells. The body needs amino acids to stay healthy. Glutamine might help treat some people with immune syste...
Detailed Description
Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin condition that typically begins in infancy or early childhood and can be highly debilitating with a marked reduction in quality of lif...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Individuals must meet all of the following criteria to be eligible for study participation:
- Be 5 to 65 years of age, inclusive.
- Able to provide informed consent.
- Be enrolled on NIAID protocol 10-I-0148 and identified on that protocol as meeting at least one of the following 3 criteria:
- Has active, moderate-to-severe AD (defined as objective SCORAD greater than or equal to 15 or total SCORAD greater than or equal to 25).
- Has a confirmed defect in mTORC1 signaling (based on T cell stimulation assay).
- Has a confirmed CBM loss-of-function gene mutation (identified by genetic sequencing and verified in vitro by testing patient cells and/or transfection of mutant gene into cell lines).
- Females of childbearing potential must agree to use adequate contraception when engaging in sexual activities that can result in pregnancy, beginning 30 days prior to day 0 through study day 120. Acceptable methods of contraception include the following:
- Continuous hormonal contraception used per label without interruption throughout the above period.
- Male or female condom with spermicide.
- Diaphragm or cervical cap with a spermicide.
- Intrauterine device.
- Be willing to allow storage of biological samples for future research purposes.
- EXCLUSION CRITERIA:
- Individuals meeting any of the following criteria will be excluded from study participation:
- Current, active infection requiring treatment.
- Current treatment with a chemotherapeutic agent.
- Participation in an ongoing research protocol evaluating an investigational agent.
- Treatment with approved prescription medications may be exclusionary, to be determined on a case-by-case basis by the principal investigator.
- Significant liver or kidney disease (serum glutamic oxaloacetic transaminase \[SGOT\], serum glutamine pyruvic transaminase \[SGPT\], or alkaline phosphatase \>2.5 (SqrRoot) upper limit of normal \[ULN\], total bilirubin \>1.5 (SqrRoot) ULN, or serum creatinine \>1.5 (SqrRoot) ULN) in the past 30 days.
- Persons with an active seizure disorder. For persons with a prior history of seizures, the person should be seizure free for 5 years and not on any anti-seizure medication in order to be enrolled into the study. (Since glutamine is metabolized to glutamate and ammonia, and glutamate is the main excitatory neurotransmitter in the central nervous system, there is a theoretical increased risk of seizures.)
- Allergy to monosodium glutamate.
- Malabsorption.
- Pregnancy.
- Breastfeeding.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Exclusion
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04019769
Start Date
March 12 2020
End Date
January 1 2021
Last Update
March 16 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892