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

Asthma in Children Clinical Trial

Official title: An Innovative Analytical Platform to Investigate the Effect and Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease in Preclinical and Clinical Studies

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

This study will involve schoolchildren (aged 6-18 years), population cohort based on differential exposure and susceptibility to allergy(paediatric population, allergic vs. healthy subjects). 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 (AR), atopic dermatitis (AD) and/or food allergy) for at least a year. Subjects will be recruited from three distinct and different geographical regions in Croatia: 2 continental regions (Zagreb, urban) and Slavonia (urban and rural) and 1 Mediterranean region (urban and rural population), differing in the levels of exposure (allergens, pollutants), consumption of water (main water source- bottled water, public water source, well water), food consumption (food packed in plastic material, use of fertilizers in agriculture), nutrition (food from marine environments, industrially processed food, homegrown food) as well as different environmental protection measures and human activities.In each region and subgroup, we will recruit 70 allergic children and 140 healthy (non-allergic) children in a case-control study protocol, summing up to al total of 630 participants.

The study will include visits:

1. Initial (screening) visit (V0 +3-6 months): written consent, assessment of inclusion and exclusion criteria, spirometry, Fractional exhaled nitric oxide (FeNO), questionnaires…

2. V2 (V0+6-9 months), questionnaires, environmental skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection stool,

3. V2-V5 (V0+months 6-30 months)- regular visits (assessment) every 6 months, stool samples (second sampling)

4. Visit 4 (V0+18-24 months): environmental assessments, skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection

5. V5 (last visit, V0+24-30 months)- final assessment of the study outcome measures, check and document consumption, adherence, preventive measures, level of control, therapy correction

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 Otorhinolaryngology- Ear, Nose, Throat (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. They will need to fulfil the ISAAC questionnaire for children perform spirometry and prick test with a standard palette of inhalational and nutritional allergens to exclude allergic diseases.

No intervention tests or methods will be involved in this study. Patients who will be involved in the study will continue to take their regular therapy (according to guidelines) i.e. conduct treatment and all other non-therapeutic measures as if they were not involved in the study. Any deterioration or emergency intervention will be specifically evaluated and recorded as additional visits. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05177744
• Study type: Observational [Patient Registry]
• Source: Children's Hospital Srebrnjak
• Status: Recruiting
• Start date: October 5, 2022
• Completion date: February 28, 2025