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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05706714
Other study ID # IFUCD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 6, 2021
Est. completion date September 1, 2023

Study information

Verified date September 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Infection-related hyperammonemia in patients with urea cycle disorders is an important cause of morbidity and mortality. The relationship between immune system cells and the metabolic pathways used by these cells and inborn errors of metabolism is still under investigation. Current studies are generally based on experiments in mice. The investigators' goal is to study specific T cell subsets to understand the effects of the urea cycle on T cells. The investigators collected blood samples from participants with lysinuric protein intolerance and urea cycle disorders for basic immunophenotyping, lymphocyte proliferation in response to phytohemagglutinin and CDmix, and cytokine analysis involving Th1, Th2, and Th17 and compared them with age-matched healthy controls. They also examined amino acid profiles in sera and supernatants before and after stimulation with PMA-ionomycin.


Description:

The investigators aim to compare cellular immune response of T cell phenotype and proliferative functions in addition to lymphocyte subset analysis between urea cycle disorders and healthy controls. Complete blood counts, immunoglobuline levels, lymptocyte subset analysis and Thelper cells will be analyzed. Additionally, T helper cells will be measured regarding their cytokine profile as Th1, Th2 and Th17. T cell proliferation response and aminoacid profiles in supernatants before and after stimulation will be measured.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date September 1, 2023
Est. primary completion date December 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 53 Years
Eligibility Inclusion Criteria: - Children without any chronic conditions and having normal immunoglobulins and lymphocyte subsets Exclusion Criteria: - For healthy control, children having any signs for primary immune deficiencies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Measurement of amino acid profile changes before and after stimulation Serum Aminoacids from periphery, in cell culture supernatants before and after stimulation will be measured baseline
Primary Measurement of Th1, Th2 and Th17 cells Th1, Th2 and Th17 cells will be measured following stimulation in cell culture baseline
Secondary Measurement of T cell proliferative capacity T cells' proliferation will be measured following stimulation in cell culture baseline
See also
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