Food HypersensitivityImptoxNCT05177744
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
An observational study of Food Hypersensitivity and Asthma in Children, run by Children's Hospital Srebrnjak at 1 site in Croatia.
Trial summary
Single-center, cross-sectional, longitudinal, observational, population based cohort study with stratified sample (by age group, gender, and residential area). Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Hypersensitivity, Asthma in Children, Rhinitis, Allergic
- How many people
- 1,156 participants
- Where
- 1 siteCroatia
- Study dates
- 5 Oct 2022to 4 Feb 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
- Additional inclusion criteria:
- Significant clinical allergy to indoor and outdoor allergens, an food allergens with positive skin prick test (SPT) and specific IgE levels (>0.35kUA/L)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Single-center, cross-sectional, longitudinal, observational, population based cohort study with stratified sample (by age group, gender, and residential area).
Read the detailed 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 cross-sectionalstudy protocol, summing up to al total of 630 participants.
The study will include visits:
- Initial (screening) visit (V0 +3-6 months): written consent, assessment of inclusion and exclusion criteria, spirometry, Fractional exhaled nitric oxide (FeNO), questionnaires…
- V2 (V0+6-9 months), questionnaires, environmental skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection stool,
- V2-V5 (V0+months 6-30 months)- regular visits (assessment) every 6 months, stool samples (second sampling)
- Visit 4 (V0+18-24 months): environmental assessments, skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection
- 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.
- Medical subject headings
- Food Hypersensitivity, Rhinitis, Allergic, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations.
Secondary outcomes (7)
Fractional exhaled nitric oxide (FeNO)
FeNO test measures the level of nitric oxide gas in an exhaled sample of breath. It is measured in "parts per billion" (ppb).
Measured: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Childhood Asthma Control Test (C-ACT)
C-ACT questionnaire will be used to tell us if the asthma treatment plan is optimal and if asthma is being properly controlled. For children 4 to 11 years maximal score is 27, and for those older then 12 years maximal score is 25. Higher scores reflect greater asthma control, and if the score is 19 or less may be a sign that asthma is not controlled as well as it could be.
Measured: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Daily burden of disease (Global evaluation)
Participants' daily burden of disease will be evaluated by visual analogue scale (VAS) Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels ≥50/100 as "High" burden.
Measured: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Daily burden of disease (affecting Nose)
Participants with AR will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels ≥50/100 as "High" burden.
Measured: 6 months
Daily burden of disease (affecting Eyes)
Participants' daily burden of the disease affecting eyes will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels ≥50/100 as "High" burden.
Measured: 6 months
Daily burden of disease (Asthma)
Participants' daily burden of asthma will be evaluated by visual analogue scale (VAS).Visual analogue scale levels <20/100 were categorized as "Low" burden and VAS levels ≥50/100 as "High" burden.
Measured: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
SCORing Atopic Dermatitis (SCORAD)
SCORAD as a clinical tool will be used to assess the extent and severity of eczema. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0- 100), B is defined as the intensity (0- 18) and C is defined as the subjective symptoms (0- 20). The maximal score of the SCORAD Index is 103.
Measured: 6 months for patients with AD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start5 Oct 2022
- Primary completion11 Apr 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,156 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Children's Hospital Srebrnjak
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Principal investigator, Mirjana Turkalj, MD, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177744
- Sponsor's protocol ID
- SCH-EU965173
- Acronym
- Imptox
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05177744
- Acronym / sponsor ID
- Imptox / SCH-EU965173
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,156 participants (actual)
- Lead sponsor
- Children's Hospital SrebrnjakUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, cross-sectional, longitudinal, observational, population based cohort study with stratified sample (by age group, gender, and residential area).
Detailed 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 cross-sectionalstudy protocol, summing up to al total of 630 participants.
The study will include visits:
- Initial (screening) visit (V0 +3-6 months): written consent, assessment of inclusion and exclusion criteria, spirometry, Fractional exhaled nitric oxide (FeNO), questionnaires…
- V2 (V0+6-9 months), questionnaires, environmental skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection stool,
- V2-V5 (V0+months 6-30 months)- regular visits (assessment) every 6 months, stool samples (second sampling)
- Visit 4 (V0+18-24 months): environmental assessments, skin prick test (APT), sIgE (+ISAC), spirometry, FeNO, blood collection
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung function tests
Time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations.
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.
7 secondary outcomes
Fractional exhaled nitric oxide (FeNO)
Time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Childhood Asthma Control Test (C-ACT)
Time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Daily burden of disease (Global evaluation)
Time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
Daily burden of disease (affecting Nose)
Time frame: 6 months
Daily burden of disease (affecting Eyes)
Time frame: 6 months
Daily burden of disease (Asthma)
Time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations
SCORing Atopic Dermatitis (SCORAD)
Time frame: 6 months for patients with AD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity and Asthma in Children, run by Children's Hospital Srebrnjak at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function tests (time frame: 6 months, Asthmatic patients will be regularly controlled even more often in case of exacerbations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.