Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy

NCT07158619 | Not Yet Recruiting DMC

• 1 other identifier: KB/61/2025
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:

• First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+/- 3 weeks).
• Second arm (initial control group - one year on a cashew nut elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks). After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Conditions

Food Allergy in Children

Keywords

food allergy, oral immunoteraphy, cashew nut allergy,

Outcome Measures

Primary Outcomes (1)

• Sustained unresponsiveness determined by the outcome of the OFC

  Percentage of patients achieving sustained unresponsiveness after 1200 mg cashew nut protein oral immunotherapy, defined as tolerating 4 g of cashew nut powder in OFC after 4 weeks of cashew nut avoidance.

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

Secondary Outcomes (16)

• Changes in cashew nut protein tolerance during OFC

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Adverse event

  11 months on the maintenance dose of OIT (±3 weeks) and a 4 week break (+/- 7 days).

• Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Basophil activation test (BAT)

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - wheal diameter in PTS

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

Study Arms (2)

Maintenance dose of cashew nut protein (1200mg) for 8 months

EXPERIMENTAL

Patients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of cashew nut protein (1200mg) for the next 8 months.

Dietary Supplement: OIT with cashew nut protein

Immunotherapy initiated after one year of cashew nut avoidance

EXPERIMENTAL

Patients assigned to the control group in the first part of the study, after one year on a cashew nut elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months.

Dietary Supplement: OIT with cashew nut protein

Interventions

OIT with cashew nut protein DIETARY_SUPPLEMENT

After 8 months of continued oral immunotherapy (OIT) with cashew nuts, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to assess desensitization. Patients who had a negative OFC after 3 months in the initial phase-confirming desensitization-will skip the pre-break OFC and proceed directly to the next stage. Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to evaluate sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed during this visit.

Immunotherapy initiated after one year of cashew nut avoidance; Maintenance dose of cashew nut protein (1200mg) for 8 months

Eligibility Criteria

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

You may qualify if:

• Cashew nut allergy confirmed prior to the initiation of immunotherapy
• Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy
• Provision of informed consent for participation in the study
• Adequate cooperation from the patient and/or their legal guardians

You may not qualify if:

• Severe asthma
• Poorly controlled mild-to-moderate asthma, defined as:
• FEV1 \< 80% (below the 5th percentile),
• FEV1/FVC ratio \< 75% (below the 5th percentile),
• Hospitalization due to asthma exacerbation within the past 12 months
• Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy
• Eosinophilic gastrointestinal disorders
• Severe, recurrent episodes of anaphylaxis within the last 6 months
• Chronic illnesses requiring ongoing treatment, including:
• Cardiac conditions
• Epilepsy
• Metabolic disorders
• Diabetes mellitus
• Use of the following medications:
• Daily oral corticosteroid therapy \>1 month within the past 12 months

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (8)

• 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

• Wang F, Robotham JM, Teuber SS, Tawde P, Sathe SK, Roux KH. Ana o 1, a cashew (Anacardium occidental) allergen of the vicilin seed storage protein family. J Allergy Clin Immunol. 2002 Jul;110(1):160-6. doi: 10.1067/mai.2002.125208.

  PMID: 12110836 BACKGROUND

• Robotham JM, Wang F, Seamon V, Teuber SS, Sathe SK, Sampson HA, Beyer K, Seavy M, Roux KH. Ana o 3, an important cashew nut (Anacardium occidentale L.) allergen of the 2S albumin family. J Allergy Clin Immunol. 2005 Jun;115(6):1284-90. doi: 10.1016/j.jaci.2005.02.028.

  PMID: 15940148 BACKGROUND

• Borres MP, Sato S, Ebisawa M. Recent advances in diagnosing and managing nut allergies with focus on hazelnuts, walnuts, and cashew nuts. World Allergy Organ J. 2022 Apr 11;15(4):100641. doi: 10.1016/j.waojou.2022.100641. eCollection 2022 Apr.

  PMID: 35493774 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

• Washio K, Nakamura M, Sato N, Hori M, Matsubara K, Ogura K, Oda Y, Fukunaga A, Yagami A, Matsunaga K. Anaphylaxis in a pectin- and cashew nut-allergic child caused by a citrus bath. Allergol Int. 2022 Jan;71(1):155-157. doi: 10.1016/j.alit.2021.07.006. Epub 2021 Aug 2. No abstract available.

  PMID: 34353728 BACKGROUND

• van der Valk JP, Gerth van Wijk R, Dubois AE, de Groot H, Reitsma M, Vlieg-Boerstra B, Savelkoul HF, Wichers HJ, de Jong NW. Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut. PLoS One. 2016 Mar 11;11(3):e0151055. doi: 10.1371/journal.pone.0151055. eCollection 2016.

  PMID: 26967158 BACKGROUND

• 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

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Katarzyna Grzela, MD, PhD

CONTACT

+48 22 3179431; katarzyna.grzela@wum.edu.pl

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)