Atopic DermatitisNCT05662800
Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy
An observational study of Atopic Dermatitis and Food Allergy, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed. Read more about this study
- Who is it for?
- Ages 4 to 36 months
- Conditions the study is for
- Atopic Dermatitis, Food Allergy, Peanut Allergy
- What is being tested?
- Assessment of peanut, tree nuts and sesame allergy
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 2 sitesPoland
- Study dates
- 17 Apr 2023to Apr 2025
- 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 4 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: The children will be recruited using mailing to general paediatric, allergy, and dermatology practices and directly to two allergy centers (Warsaw and Bydgoszcz).
Who may be able to join
- moderate or severe eczema and/or egg allergy,
- at least one complementary food already introduced,
- signed informed consent.
- Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors or systemic treatment as well as history of hospital admission.
- Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will be identified by a convincing history of a reaction in the presence of a positive skin prick test (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm with no history of a reaction.
Who cannot join
- inability to withdraw antihistamines for at least 5 days prior to testing,
- use of prohibited medication such as beta-blockers, angiotensin-converting-enzyme inhibitors (ACE-I) and biological treatments affecting the immunological response,
- uncontrolled asthma or eczema which does not warrant readiness for a food challenge within the study time frame,
- chronic urticaria,
- chronic systemic diseases.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
Bydgoszcz, 85-067
Aneta Krogulska, MD, Prof., +48 52 585 48 50
Julia Gawryjołek, MD, PhD, +48 52 585 48 50, gawryjolek.j@gmail.com
- Recruiting
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Klaudia Ryczaj, MD, +48 22 317 94 19, klaudia.ryczaj@gmail.com
About this study
The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.
Read the detailed description
Introduction: Peanut allergy (PA) has become a health concern world-wide for several decades. Sesame allergy, although less prevalent, is also causing growing concern. Peanut, tree nuts, and sesame allergy co-exist in 60% of children. Although the majority of PA cases come from the general population, there are well-established risk factors for this allergy, such as eczema and egg allergy. In the Learning Early About Peanut (LEAP) Study, early introduction of peanut into the diet of children with moderate-to-severe eczema or egg allergy was proven to be effective in PA prevention. This strategy has now been adopted by national allergy societies in the USA and Australia as part of the weaning guidance for the high-risk populations.However, it is not known whether early introduction of peanut is also justified in other populations where peanut consumption has traditionally been lower. Getting insight into the prevalence of nut and sesame allergy in the cohort of infants and toddlers in Central Europe is needed to guide early dietary intervention strategies.
Methods: 240 children with eczema or egg allergy will undertake extensive assessment of peanut, tree nuts (hazelnut, almond, cashew, pistachio, walnut, macadamia) and sesame allergy status through consumption history, skin testing, specific immunoglobulin E measurement (sIgE) and oral food challenges (OFCs).
- Conditions
- Atopic Dermatitis, Food Allergy, Peanut Allergy, Tree Nut Allergy
- Being tested
- Assessment of peanut, tree nuts and sesame allergy
- Keywords
- atopic dermatitis, peanuts, tree nuts, sesame, food allergy, children
- Medical subject headings
- Dermatitis, Atopic, Food Hypersensitivity, Peanut Hypersensitivity, Nut Hypersensitivity, SeSAME syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of peanut, tree nuts and sesame allergyDiagnostic test
Children will undergo skin prick testing with the following allergens: commercial extracts for peanut, hazelnut, almond, cashew, pistachio, walnut, macadamia, sesame, Timothy grass, and birch pollen; positive and negative control; peanut butter and tahini (sesame) paste.
Specific IgE levels will be quantified to all the above-listed tree nuts, peanuts, sesame seed and peanut components (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, Ara h 9).
Children will undertake cumulative or incremental oral food challenge with peanut, sesame and tree nuts, depending on the risk assessment based on patient's medical history and results of diagnostic tests.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy
Based on data related to allergen consumption, SPT, and OFC, patients will be classified as allergic to peanuts and sesame or non-allergic. Based on the results of SPT, sIgE, and OFCs are performed in exceptional situations, patients will be classified as allergic, non-allergic, or likely not allergic to selected tree nuts.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start17 Apr 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Foundation, Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor
- Investigators
- Marek Kulus, MD, Prof., Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662800
- Sponsor's protocol ID
- RG 2/2021
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
Publications
Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
PubMed 31866098Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.
PubMed 25705822Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, Brough H, Marrs T, Radulovic S, Craven J, Flohr C, Lack G; EAT Study Team. Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. N Engl J Med. 2016 May 5;374(18):1733-43. doi: 10.1056/NEJMoa1514210. Epub 2016 Mar 4.
PubMed 26943128Du Toit G, Katz Y, Sasieni P, Mesher D, Maleki SJ, Fisher HR, Fox AT, Turcanu V, Amir T, Zadik-Mnuhin G, Cohen A, Livne I, Lack G. Early consumption of peanuts in infancy is associated with a low prevalence of peanut allergy. J Allergy Clin Immunol. 2008 Nov;122(5):984-91. doi: 10.1016/j.jaci.2008.08.039.
PubMed 19000582Togias A, Cooper SF, Acebal ML, Assa'ad A, Baker JR Jr, Beck LA, Block J, Byrd-Bredbenner C, Chan ES, Eichenfield LF, Fleischer DM, Fuchs GJ 3rd, Furuta GT, Greenhawt MJ, Gupta RS, Habich M, Jones SM, Keaton K, Muraro A, Plaut M, Rosenwasser LJ, Rotrosen D, Sampson HA, Schneider LC, Sicherer SH, Sidbury R, Spergel J, Stukus DR, Venter C, Boyce JA. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017 Jan;139(1):29-44. doi: 10.1016/j.jaci.2016.10.010.
PubMed 28065278Ryczaj K, Szczukocka-Zych A, Wawszczak M, Gawryjolek J, Krogulska A, Krawiec M, Horvath A, Szajewska H, Santos A, Bahnson HT, Kulus M. Development of peanut, sesame and tree nut allergy in Polish children at high risk of food allergy: a protocol for a cross-sectional study. BMJ Open. 2023 Nov 16;13(11):e074168. doi: 10.1136/bmjopen-2023-074168.
PubMed 37973545
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy
- ClinicalTrials.gov ID
- NCT05662800
- Acronym / sponsor ID
- RG 2/2021
- Conditions
- Atopic Dermatitis, Food Allergy, Peanut Allergy, Tree Nut Allergy
- Keywords
- atopic dermatitis, peanuts, tree nuts, sesame, food allergy, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Nutricia Foundation, Thermo Fisher Scientific, Inc
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Dec 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.
The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.
Detailed description
Introduction: Peanut allergy (PA) has become a health concern world-wide for several decades. Sesame allergy, although less prevalent, is also causing growing concern. Peanut, tree nuts, and sesame allergy co-exist in 60% of children. Although the majority of PA cases come from the general population, there are well-established risk factors for this allergy, such as eczema and egg allergy. In the Learning Early About Peanut (LEAP) Study, early introduction of peanut into the diet of children with moderate-to-severe eczema or egg allergy was proven to be effective in PA prevention. This strategy has now been adopted by national allergy societies in the USA and Australia as part of the weaning guidance for the high-risk populations.However, it is not known whether early introduction of peanut is also justified in other populations where peanut consumption has traditionally been lower. Getting insight into the prevalence of nut and sesame allergy in the cohort of infants and toddlers in Central Europe is needed to guide early dietary intervention strategies.
Methods: 240 children with eczema or egg allergy will undertake extensive assessment of peanut, tree nuts (hazelnut, almond, cashew, pistachio, walnut, macadamia) and sesame allergy status through consumption history, skin testing, specific immunoglobulin E measurement (sIgE) and oral food challenges (OFCs).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The children will be recruited using mailing to general paediatric, allergy, and dermatology practices and directly to two allergy centers (Warsaw and Bydgoszcz).
Key inclusion criteria (5 listed)
- moderate or severe eczema and/or egg allergy,
- at least one complementary food already introduced,
- signed informed consent.
- Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors or systemic treatment as well as history of hospital admission.
- Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will be identified by a convincing history of a reaction in the presence of a positive skin prick test (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm with no history of a reaction.
Key exclusion criteria (5 listed)
- inability to withdraw antihistamines for at least 5 days prior to testing,
- use of prohibited medication such as beta-blockers, angiotensin-converting-enzyme inhibitors (ACE-I) and biological treatments affecting the immunological response,
- uncontrolled asthma or eczema which does not warrant readiness for a food challenge within the study time frame,
- chronic urticaria,
- chronic systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of peanut, tree nuts and sesame allergyChildren will undergo skin prick testing with the following allergens: commercial extracts for peanut, hazelnut, almond, cashew, pistachio, walnut, macadamia, sesame, Timothy grass, and birch pollen; positive and negative control; peanut butter and tahini (sesame) paste. Specific IgE levels will be quantified to all the above-listed tree nuts, peanuts, sesame seed and peanut components (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, Ara h 9). Children will undertake cumulative or incremental oral food challenge with peanut, sesame and tree nuts, depending on the risk assessment based on patient's medical history and results of diagnostic tests. | Diagnostic test | – |
Primary outcome
The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy
Time frame: 1-2 days
Based on data related to allergen consumption, SPT, and OFC, patients will be classified as allergic to peanuts and sesame or non-allergic. Based on the results of SPT, sIgE, and OFCs are performed in exceptional situations, patients will be classified as allergic, non-allergic, or likely not allergic to selected tree nuts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 31866098Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
- Background: PubMed 25705822Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.
- Background: PubMed 26943128Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, Brough H, Marrs T, Radulovic S, Craven J, Flohr C, Lack G; EAT Study Team. Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. N Engl J Med. 2016 May 5;374(18):1733-43. doi: 10.1056/NEJMoa1514210. Epub 2016 Mar 4.
- Background: PubMed 19000582Du Toit G, Katz Y, Sasieni P, Mesher D, Maleki SJ, Fisher HR, Fox AT, Turcanu V, Amir T, Zadik-Mnuhin G, Cohen A, Livne I, Lack G. Early consumption of peanuts in infancy is associated with a low prevalence of peanut allergy. J Allergy Clin Immunol. 2008 Nov;122(5):984-91. doi: 10.1016/j.jaci.2008.08.039.
- Background: PubMed 28065278Togias A, Cooper SF, Acebal ML, Assa'ad A, Baker JR Jr, Beck LA, Block J, Byrd-Bredbenner C, Chan ES, Eichenfield LF, Fleischer DM, Fuchs GJ 3rd, Furuta GT, Greenhawt MJ, Gupta RS, Habich M, Jones SM, Keaton K, Muraro A, Plaut M, Rosenwasser LJ, Rotrosen D, Sampson HA, Schneider LC, Sicherer SH, Sidbury R, Spergel J, Stukus DR, Venter C, Boyce JA. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017 Jan;139(1):29-44. doi: 10.1016/j.jaci.2016.10.010.
- Derived from this study: PubMed 37973545Ryczaj K, Szczukocka-Zych A, Wawszczak M, Gawryjolek J, Krogulska A, Krawiec M, Horvath A, Szajewska H, Santos A, Bahnson HT, Kulus M. Development of peanut, sesame and tree nut allergy in Polish children at high risk of food allergy: a protocol for a cross-sectional study. BMJ Open. 2023 Nov 16;13(11):e074168. doi: 10.1136/bmjopen-2023-074168.
- Individual participant dataSharing planned: Yes. The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
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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.
Marek Kulus, MD, Prof. principal investigator
Medical University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Food Allergy, run by Medical University of Warsaw at 2 sites in Poland.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Kulus, MD, Prof. (+48 22 317 94 19, marek.kulus@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662800, which also lists 6 linked publications.
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 19 Apr 2023.