Glutamine Supplementation in People With Immune Dysregulation

NCT04019769 | Withdrawn Early Phase 1

• 2 other identifiers: 19012119-I-0121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 system problems like atopic dermatitis. Objective: To study the safety and effectiveness of glutamine supplements for people with certain immune system problems. Eligibility: People ages 5-65 with atopic dermatitis and other immune system problems Design: Participants will be screened in another protocol. Participants will have 8 visits. Visit 1 includes: Physical exam Medical history Blood and urine tests Saliva sample Nutrition assessment For participants with AD, photographs of the skin Participants will get a diary to record their symptoms every day during the study. They will record any glutamine side effects and bring the diary to every visit. Visit 2 is about 1 month after visit 1. Participants will repeat visit 1 tests and get glutamine to take home. It is a powder that can be added to drinks or food. They will take it twice a day for 3 months. They will record their doses in a diary each day and bring the diary to all visits. Participants will have a phone call 5 days after starting glutamine to discuss how they are feeling. Visit 3 is about 7 days after participants start taking glutamine. They will have blood tests. Visits 4, 5, and 6 occur each month participants are taking glutamine. Participants will repeat visit 1 tests. Participants will stop taking glutamine after visit 6. Visits 7 and 8 occur 1 and 3 months after participants stop taking glutamine. Participants will repeat visit 1 tests.

Conditions

Eczema; MTOROC1 Signaling

Keywords

Eczema; MTORC1 Signaling; CBM Complex

Outcome Measures

Primary Outcomes (1)

• To characterize the safety and tolerability of glutamine supplementation in patients with immune disregulation.

  assess safety and tolerability of glutamine

  1 year

Study Arms (1)

1

EXPERIMENTAL

All patients will receive L-glutamine 10-30mg daily based on weight for 3 months

Drug: L-glutamine

Interventions

L-glutamine DRUG

product will be obtained by Endari and administered by NIH pharmacy. Patient will take supplement as prescribed

1

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Eczema

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Joshua D Milner, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 15, 2019
• Study Start: March 12, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

US (1)