Efficacy of Cashew Nut Protein Immunotherapy
ConditionFood Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Cashew immunotherapy
Combination productFollowing 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).
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: Cashew ImmunotherapyExperimental treatment 1 intervention
Group B: Cashew avoidanceNo intervention 0 interventions
Trial outcomes
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.
Time frame
Up to 60 weeks of OIT (oral immunotherapy)Secondary outcomes
1
Cashew partial tolerance
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
Time frame
Up to 60 weeks of OIT (oral immunotherapy)2
OIT safety
Number and type of side effects during oral desensitization with cashew protein, divided into mild, moderate and severe.
Time frame
Up to 60 weeks of OIT (oral immunotherapy)3
Wheal diameter in skin prick tests
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.
Time frame
Up to 60 weeks of OIT (oral immunotherapy)4
SIgE (specific immunoglobulin E) (kUA/l) levels
Difference in sIgE (specific immunoglobulin E) (kUA/l) 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.
Time frame
Up to 60 weeks of OIT (oral immunotherapy)Sponsors and contacts
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Source ClinicalTrials.gov