Efficacy of Cashew Nut Protein Immunotherapy

March 22, 2024 updated by: Medical University of Warsaw
It is a randomized, sigle-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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

According to Polish data, in the population of children suspected of food allergy, cashew was the third nut found to be allergic, after peanut and hazelnut. Allergic reactions to nuts can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.

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.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 4 and 17 years,
  • IgE-mediated cashew allergy confirmed with positive skin prick tests with cashew allergens (diameter of the wheal greater than 3mm) and/or specific IgE 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:

  • no confirmed allergy to cashew,
  • negative provocation test with cashew,
  • severe asthma,
  • mild/moderate asthma poorly controlled: FEV1<80% (less than 5 perc), FEV1/FVC<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, calcium channel inhibitors,
  • pregnancy,
  • lack of consent to participate in the study,
  • lack of patient cooperation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cashew Immunotherapy
Children with cashew allergy receiving OIT.
Combination product: 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).
No Intervention: Cashew avoidance
Children with cashew allergy not receiving OIT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cashew full tolerance
Time Frame: Up to 60 weeks of OIT
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cashew partial tolerance
Time Frame: Up to 60 weeks of OIT
Percentage of children with partial tolerance, defined as an increase in the tolerated dose by at least 10-fold and tolerance of at least 1.2g of cashew protein but less than 4g of cashew protein at the end of 12 weeks of cashew protein immunotherapy at the maintenance dose or after 60 weeks of immunotherapy
Up to 60 weeks of OIT
OIT safety
Time Frame: Up to 60 weeks of OIT
Number and type of side effects during oral desensitization with cashew protein, divided into mild, moderate and severe.
Up to 60 weeks of OIT
Wheal diamater in skin prick tests
Time Frame: Up to 60 weeks of OIT
Difference in wheal diameter in skin prick tests between groups before and after completion of 12 weeks of cashew protein immunotherapy at the maintenance dose or after 60 weeks of immunotherapy.
Up to 60 weeks of OIT
SIgE and IgG 4 levels
Time Frame: Up to 60 weeks of OIT
Difference in sIgE and IgG4 levels against cashew, walnut, pistachio, peanut, hazelnut and almond allergens evaluated between groups 12 weeks of immunotherapy at maintenance dose or after 60 weeks of immunotherapy.
Up to 60 weeks of OIT
BAT scores
Time Frame: Up to 60 weeks of OIT
Difference in BAT test scores between groups before and after 12 weeks of immunotherapy at maintenance dose or after 60 weeks of immunotherapy
Up to 60 weeks of OIT
Quality of life- FAQLQ
Time Frame: Up to 60 weeks of OIT
Assessment of quality of life before and after desensitization (impact on families' lives) using FAQLQ. In children up to 12 years old we use FAQLQ-0-12 and FAQLQ-CH (children 8-12 years old). For children 13-17 years old we use FAQLQ-TF
Up to 60 weeks of OIT
Air condensate
Time Frame: Up to 60 weeks of OIT
Evaluation of pro-inflammatory cytokine levels in exhaled air condensate
Up to 60 weeks of OIT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Agnieszka Szczukocka-Zych, MD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 21, 2026

Study Completion (Estimated)

April 21, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cashew Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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