Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease

NCT05177744 | Completed

• 1 other identifier: SCH-EU965173
• Study Type: observational
• Target: 1,156
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, cross-sectional, longitudinal, observational, population based cohort study with stratified sample (by age group, gender, and residential area).

Conditions

Food Hypersensitivity; Asthma in Children; Rhinitis, Allergic; Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Lung function tests

  Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC) and the ratio of the two volumes (FEV1/FVC) will be recorded for each patient at each visit. FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. It's measured in % of predicted values which are the average readings that would be expected in a healthy person of similar age, gender, body size, and ethnicity. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.

  6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations.

Secondary Outcomes (7)

• Fractional exhaled nitric oxide (FeNO)

  6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations

• Childhood Asthma Control Test (C-ACT)

  6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations

• Daily burden of disease (Global evaluation)

  6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations

• Daily burden of disease (affecting Nose)

  6 months

• Daily burden of disease (affecting Eyes)

  6 months

Other Outcomes (1)

• ISAC platform

  Blood samples will be collected twice (at baseline and after 6 months)

Study Arms (6)

allergic (Zagreb, urban)

Participants will be selected based on proven sensitization to at least one food allergen (preferentially but not only to seafood) with a diagnosis of at least one allergic disease (i.e. allergic asthma, allergic rhinitis, atopic dermatitis and/or food allergy) for at least a year. Subjects will be recruited from continental region in Croatia - Zagreb (urban)

healthy subjects (Zagreb, urban)

Healthy subjects that will be recruited from continental region in Croatia - Zagreb (urban). Negative history of allergic diseases, as well as other severe chronic diseases, including malignant, autoimmune, or mental illnesses.

allergic (Slavonia, urban and rural)

Participants will be selected based on proven sensitization to at least one food allergen (preferentially but not only to seafood) with a diagnosis of at least one allergic disease (i.e. allergic asthma, allergic rhinitis, atopic dermatitis and/or food allergy) for at least a year. Subjects will be recruited from continental region in Croatia - Slavonia (urban and rural)

healthy subjects (Slavonia, urban and rural)

Healthy subjects that will be recruited from continental region in Croatia -(Slavonia, urban and rural). Negative history of allergic diseases, as well as other severe chronic diseases, including malignant, autoimmune, or mental illnesses.

allergic Mediterranean region (urban and rural population)

Participants will be selected based on proven sensitization to at least one food allergen (preferentially but not only to seafood) with a diagnosis of at least one allergic disease (i.e. allergic asthma, allergic rhinitis, atopic dermatitis and/or food allergy) for at least a year. Subjects will be recruited from mediterranean region in Croatia - urban and rural

healthy subjects Mediterranean region (urban and rural population)

Healthy subjects that will be recruited from mediterranean region in Croatia -urban and rural. Negative history of allergic diseases, as well as other severe chronic diseases, including malignant, autoimmune, or mental illnesses.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants in the control group will be involved in collaboration with other outpatient clinics (eg. from surgical outpatient clinics who have had minor surgical procedures, from the ENT outpatient clinics at least 7 days after acute ear inflammation or laryngitis, from emergency ambulatory patients at least 7 days after acute respiratory illness, etc.). All participants who will be included in the control group should have a negative history of allergic diseases, as well as other severe chronic diseases, including malignant, autoimmune, or mental illnesses.

You may qualify if:

• Proven sensitization to at least one food allergen with a diagnosis of at least one allergic disease for at least one year
• Clinical diagnosis of allergic rhinitis (AR) for at least 1 year with symptoms of the nose, induced after exposure to allergens via IgE-mediated hypersensitivity reactions (symptoms of watery rhinorrhea, nasal obstruction, nasal itching and sneezing).
• Diagnosis of atopic dermatitis (AD) with AD symptoms lasting for more than 3 months, with or without food allergy
• Significant clinical allergy to indoor and outdoor allergens, an food allergens with positive skin prick test (SPT) and specific IgE levels (\>0.35kUA/L)

You may not qualify if:

• Known inborn or perinatal pulmonary disease;
• Pulmonary malformation
• Oxygen therapy after birth with a duration of more than 24 h
• Ventilator support or mechanical ventilation after birth
• Diagnosis of cystic fibrosis
• Primary ciliary dyskinesia
• Heart failure diagnosed after birth affecting pulmonary circulation
• Major respiratory diseases such as e.g. interstitial lung disease and other congenital and serious chronic disease
• Fever of at least 38.5 °C during the last two weeks prior to the planned visit

Sponsors & Collaborators

• Children's Hospital Srebrnjak: lead
• University of Belgrade: collaborator

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, City of Zagreb, 10000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and stool samples. Blood samples and stool samples will be collected twice (at baseline and after 6 months)

MeSH Terms

Conditions

Food Hypersensitivity; Rhinitis, Allergic; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 5, 2022
• Study Start: October 5, 2022
• Primary Completion: April 11, 2024
• Study Completion: February 4, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

CR (1)