Treg Effector Function and Th2/Treg Ratio in Allergic Conjunctivitis: Effect of Desensitization Therapy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-30
SponsorInstituto de Oftalmología Fundación Conde de Valenciana

About this trial

This study aims to evaluate the effector function and expression of TIGIT and PD-1 on Tregs, as well as the Th2/Treg ratio, in patients with allergic conjunctivitis with and without desensitization therapy, compared to healthy controls.

Peripheral blood and tear samples will be collected once at enrollment. Treg and Th2 populations will be immunophenotyped, TIGIT and PD-1 expression assessed, and functional assays performed. Cytokine and antibody (IgE, IgG4) concentrations will be measured in serum and tears.

Results will be analyzed using descriptive statistics, Shapiro-Wilk test for distribution, t-tests or ANOVA for group comparisons, and correlation analyses for associations, with p\<0.05 considered significant. This study seeks to identify immunological markers associated with disease severity and treatment response, potentially informing future therapeutic strategies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects aged between 5 and 30 years, of either sex.

Subjects with a confirmed diagnosis of allergic conjunctivitis.

Presence of active symptoms.

Positive skin tests.

Disqualifiers

Subjects who have had an infection within the two months prior to sample collection.

Patients with other active systemic allergic diseases (such as bronchial asthma, dermatitis, among others).

Subjects with chronic-degenerative or autoimmune diseases.

Subjects who have received topical immunosuppressive treatment in the last two months.

Trial population

The study subjects are patients recruited from the outpatient clinic of "Clinical Immunology" at Instituto de Oftalmologia Conde de Valenciana. All patients are evaluated by specialists in ophthalmology and allergy.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Conjunctivitis Allergic with allergen-specific immunotherapy (AIT)
Group B: Conjunctivitis Allergic without allergen-specific immunotherapy (AIT)
Group C: Control group

Trial outcomes

Primary outcomes

1

To evaluate the effector function and the expression of TIGIT and PD-1 molecules on regulatory T cells, as well as the Th2/Treg, in patients with allergic conjunctivitis with and without allergen-specific immunotherapy, and in healthy control subjects.

Patients with allergic conjunctivitis, both with and without desensitization treatment, as well as healthy subjects as a control group, will be included in the study. Peripheral blood and tear samples will be collected from all participants. Peripheral blood samples will be used for immunophenotyping of Treg and Th2 lymphocytes and for assessing the expression levels of the effector molecules TIGIT and PD-1.

Time frame
At baseline (single assessment at enrollment in all study and control groups)
2

Proportion of Treg and Th2 lymphocytes and Th2/Treg ratio in peripheral blood

Peripheral blood mononuclear cells will be immunophenotyped to quantify Treg and Th2 populations and calculate the Th2/Treg ratio.

Time frame
At baseline (single assessment at enrollment in all study and control groups)
3

Cytokine profile associated with Treg and Th2 lymphocytes in serum and tears

Concentrations of cytokines related to Treg (e.g., IL-10) and Th2 (e.g., IL-4, IL-5, IL-13) will be measured in serum and tear samples.

Time frame
At baseline (single assessment at enrollment in all study and control groups)
4

Effector function of Treg lymphocytes assessed by TIGIT and PD-1 expression and functional assays.

Treg cells will be analyzed for expression of effector molecules TIGIT and PD-1, and functional assays will be performed to assess suppressive capacity.

Time frame
At baseline (single assessment at enrollment in all study and control groups)

Secondary outcomes

1

Concentration of IgE and IgG4 antibodies in serum and tears

Serum and tear samples will be analyzed to determine levels of IgE and IgG4 antibodies.

Time frame
At baseline (single assessment at enrollment in all study and control groups)
2

Correlation of immunological parameters with ocular symptom severity and treatment response

Associations between immunological markers (Treg/Th2 ratio, cytokine levels, IgE/IgG4 concentrations, TIGIT/PD-1 expression) and clinical outcomes will be evaluated.

Time frame
At enrollment (clinical evaluation performed once in all study and control groups)

Other outcomes

Sponsors and contacts

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