Efficacy of Cashew Nut Protein Immunotherapy

NCT06328504 | Recruiting

• 1 other identifier: Cashew Protocol
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with cashew protein compared with standard treatment (elimination diet) in pediatric patients with cashew allergy.

Conditions

Food Allergy

Keywords

cashew; food allergy; immunotherapy; children

Outcome Measures

Primary Outcomes (1)

• Cashew full tolerance

  Percentage of children tolerating a single dose of 4g of cashew protein after 12 weeks of immunotherapy at a maintenance dose.

  Up to 60 weeks of OIT (oral immunotherapy)

Secondary Outcomes (8)

• Cashew partial tolerance

  Up to 60 weeks of OIT (oral immunotherapy)

• OIT safety

  Up to 60 weeks of OIT (oral immunotherapy)

• Wheal diameter in skin prick tests

  Up to 60 weeks of OIT (oral immunotherapy)

• SIgE (specific immunoglobulin E) (kUA/l) levels

  Up to 60 weeks of OIT (oral immunotherapy)

• Basophil activation test (BAT)

  Up to 60 weeks of OIT (oral immunotherapy)

Study Arms (2)

Cashew Immunotherapy

EXPERIMENTAL

Children with cashew allergy receiving OIT (OIT-oral immunotherapy).

Combination Product: Cashew immunotherapy

Cashew avoidance

NO INTERVENTION

Children with cashew allergy not receiving OIT (OIT-oral immunotherapy).

Interventions

Cashew immunotherapy COMBINATION_PRODUCT

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 Immunotherapy

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 4 and 17 years,
• 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.

You may not qualify if:

• no confirmed allergy to cashew,
• 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,

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Related Publications (13)

• 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.

  PMID: 29205393 BACKGROUND

• 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.

  PMID: 36185550 BACKGROUND

• 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.

  PMID: 35001400 BACKGROUND

• 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.

  PMID: 23195525 BACKGROUND

• 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.

  PMID: 16597075 BACKGROUND

• 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.

  PMID: 28065342 BACKGROUND

• 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.

  PMID: 37038747 BACKGROUND

• 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.

  PMID: 25613427 BACKGROUND

• 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.

  PMID: 31866098 BACKGROUND

• 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.

  PMID: 35000223 BACKGROUND

• 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.

  PMID: 36909898 BACKGROUND

• 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.

  PMID: 37545822 BACKGROUND

• 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.

  PMID: 40592755 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Agnieszka Szczukocka-Zych, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Grzela, PhD, MD

CONTACT

+48223179431; katarzyna.grzela@wum.edu.pl

Agnieszka Szczukocka-Zych, MD

CONTACT

+48223179427; agnieszka.szczukocka-zych@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: March 28, 2024
• Primary Completion: April 21, 2026
• Study Completion (Estimated): April 21, 2027
• Last Updated: January 30, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)