Study Results
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Basic Information
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RECRUITING
NA
39 participants
INTERVENTIONAL
2024-03-28
2027-04-21
Brief Summary
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Detailed Description
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An effective and safe alternative to allergen avoidance strategies may be the use of oral specific immunotherapy.
In this study 39 children, aged 4 to 17 years with a diagnosis of IgE-dependent allergy to cashew, confirmed by an open oral provocation test (OFC; the first provocation before starting oral desensitization), will be randomly (2:1) assigned to two groups. The first group will be desensitized with a maintenance dose - 1200mg of cashew protein, while the second group - the control group - will be offered standard management - avoidance of cashew consumption.
Patients in the control group will be offered immunotherapy at the end of the study if its effectiveness is confirmed.
The desensitization procedure was planned in accordance with the guidelines for immunotherapy in food allergy of the European Academy of Allergology and Clinical Immunology.
The source of cashew protein is flour. The first dose of immunotherapy is given to patients in the intervention group in the hospital ward. The size of the initial dose depends on the symptom-triggering dose during the initial oral food provocation with cashew protein.
Every 2 weeks in the hospital setting, another higher dose of cashew protein will be given to the child. The requirement for increasing the dose of cashew is to achieve full tolerance of the previous dose. The maximum duration of this phase is 60 weeks.
After the maximum dose is tolerated, desensitization will continue for 12 weeks - the maintenance phase of desensitization.
The maintenance dose is 1200mg of cashew protein. The duration of the maintenance phase is 12 weeks (+/-3 weeks). After 12 weeks +/-3 weeks of maintenance dose, OFC and cashew protein tolerance assessment will be performed. Confirmation of complete cashew tolerance is the tolerance of a dose of 4043mg of cashew protein. Primary outcomes include the proportion of participants tolerating a single dose of 4043mg cashew protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of cashew protein in each group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cashew Immunotherapy
Children with cashew allergy receiving OIT (OIT-oral immunotherapy).
Cashew immunotherapy
Following the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +/- 3 weeks).
Cashew avoidance
Children with cashew allergy not receiving OIT (OIT-oral immunotherapy).
No interventions assigned to this group
Interventions
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Cashew immunotherapy
Following the building-up phase (up to 60 weeks), patients will receive a daily low dose of cashew flour (1200 mg cashew protein) mixed with well-tolerated fruit mousse for 3 months (12 +/- 3 weeks).
Eligibility Criteria
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Inclusion Criteria
* IgE (immunoglobulin E) -mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE (immunoglobulin E) level greater than 0.35-kilo units of Allergen per liter (kUA/l),
* allergic reaction to cashew protein during oral food challenge (OFC),
* Signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
* Patient's and caregivers' cooperation with the researcher.
Exclusion Criteria
* negative provocation test with cashew,
* severe asthma,
* mild/moderate asthma poorly controlled: FEV1 (forced expiratory volume at one second) \<80% (less than 5 perc), FEV1/FVC (forced expiratory volume at one second/forced vital capacity) \<75% (less than 5 perc), hospitalization for asthma exacerbation in the past 12 months,
* oral/sublingual/subcutaneous immunotherapy to other allergens during the study,
* eosinophilic gastroenteritis,
* chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
* taking medications:
* oral, daily steroid therapy \>1 month in the past 12 months,
* a minimum of 2 times oral steroid therapy (a period of at least 7 days) in the past 12 months,
* one-time oral steroid therapy (min. 7 days) in the last 3 months,
* biological treatment,
* need to take antihistamines continuously,
* therapy with β-blockers, ACE-inhibitors (angiotensin converting enzyme), calcium channel inhibitors,
* pregnancy,
* lack of consent to participate in the study,
* lack of patient cooperation.
4 Years
17 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Agnieszka Szczukocka-Zych, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
Bognanni A, Chu DK, Firmino RT, Arasi S, Waffenschmidt S, Agarwal A, Dziechciarz P, Horvath A, Jebai R, Mihara H, Roldan Y, Said M, Shamir R, Bozzola M, Bahna S, Fiocchi A, Waserman S, Schunemann HJ, Brozek JL; WAO DRACMA Guideline Group. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) guideline update - XIII - Oral immunotherapy for CMA - Systematic review. World Allergy Organ J. 2022 Sep 8;15(9):100682. doi: 10.1016/j.waojou.2022.100682. eCollection 2022 Sep.
de Silva D, Rodriguez Del Rio P, de Jong NW, Khaleva E, Singh C, Nowak-Wegrzyn A, Muraro A, Begin P, Pajno G, Fiocchi A, Sanchez A, Jones C, Nilsson C, Bindslev-Jensen C, Wong G, Sampson H, Beyer K, Marchisotto MJ, Fernandez Rivas M, Meyer R, Lau S, Nurmatov U, Roberts G; GA2LEN Food Allergy Guidelines Group. Allergen immunotherapy and/or biologicals for IgE-mediated food allergy: A systematic review and meta-analysis. Allergy. 2022 Jun;77(6):1852-1862. doi: 10.1111/all.15211. Epub 2022 Jan 19.
Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
Anagnostou A. Food immunotherapy: current status and future needs. Expert Rev Clin Immunol. 2023 Jun;19(6):561-563. doi: 10.1080/1744666X.2023.2201438. Epub 2023 Apr 11. No abstract available.
Koplin JJ, Wake M, Dharmage SC, Matheson M, Tang ML, Gurrin LC, Dwyer T, Peters RL, Prescott S, Ponsonby AL, Lowe AJ, Allen KJ; HealthNuts study group. Cohort Profile: The HealthNuts Study: Population prevalence and environmental/genetic predictors of food allergy. Int J Epidemiol. 2015 Aug;44(4):1161-71. doi: 10.1093/ije/dyu261. Epub 2015 Jan 21.
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.
Elizur A, Appel MY, Nachshon L, Levy MB, Epstein-Rigbi N, Koren Y, Holmqvist M, Porsch H, Lidholm J, Goldberg MR. Cashew oral immunotherapy for desensitizing cashew-pistachio allergy (NUT CRACKER study). Allergy. 2022 Jun;77(6):1863-1872. doi: 10.1111/all.15212. Epub 2022 Jan 15.
Chojnowska-Wojtowicz M, Lyzwa K, Zielinska J, Zagorska W, Grzela K. Prevalence of nut allergen sensitization among children in central Poland. Postepy Dermatol Alergol. 2023 Feb;40(1):40-46. doi: 10.5114/ada.2022.124730. Epub 2023 Feb 27.
Lyzwa K, Chojnowska-Wojtowicz M, Zielinska J, Zagorska W, Kulus M, Grzela K. Sensitization to nut allergens in children with food allergy and other atopic diseases - just a coexistence? Postepy Dermatol Alergol. 2023 Jun;40(3):402-410. doi: 10.5114/ada.2023.128991. Epub 2023 Jul 16.
Szczukocka A, Pietrzyk-Kozinska M, Zielinska J, Krupa-Laska A, Krejner-Bienias A, Kulus M, Grzela K. Efficacy of cashew nut protein immunotherapy: protocol for a single-centre randomised controlled trial in a Polish paediatric population. BMJ Open. 2025 Jul 1;15(7):e101139. doi: 10.1136/bmjopen-2025-101139.
Other Identifiers
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Cashew Protocol
Identifier Type: -
Identifier Source: org_study_id
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