Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-17
SponsorChinese University of Hong Kong
About this trial
As the global prevalence of food allergy steadily increases, tree nut (TN) becomes one of the main triggers of food-allergic reactions and food anaphylaxis. Since there is no effective cure, TN-allergic patients and their families must continue to live with this chronic, disabling condition while avoiding allergens and responding to allergic reactions with emergency treatment. An emerging experimental treatment for food allergy is oral immunotherapy (OIT). Tree nut OIT appears promising in preliminary studies but there are concerns about the high risk of adverse reactions to TNs used in the treatment. The rate of remission with TN OIT is also lacking. Identification of OIT regimes with increased efficacy and safety is urgently needed. The investigators revealed that boiled cashews had lower allergenic potential but retained mast cell reactivity. The aim of this proposed study is to investigate the efficacy and safety of a novel treatment strategy for TN-allergic individuals, whereby the investigators hypothesized that consuming increasing quantities of boiled cashews can induce desensitization/ remission to roasted tree nuts in children with cashew allergies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 2 year and 17 years of age;
Either sex, and of any race and ethnicity;
>7kg (the weight considered safe for the administration of an adrenaline autoinjector) (e.g. Jext);
Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashew nut and a positive SPT (>=3mm than control) or sIgE to cashew nut (of at least 0.35 kUA) at screening.
Disqualifiers
History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
Reacting to the placebo component during the study entry DBPCFC
Trial design
Design model
Parallel
Treatments tested in this trial
Cashew oral immunotherapy
Other interventionCashew Flour (boiled/ roasted) that is prepared under food manufacturing regulations
Placebo oral immunotherapy
Other interventionPlacebo oral immunotherapy consists of corn flour with food colouring that has similar appearance, taste and smell to the active product
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Cashew Oral ImmunotherapyActive comparator 1 intervention
Group B: Placebo Oral ImmunotherapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of cashew-allergic subjects who by T1 DBPCFC tolerate the full challenge i.e. a cumulative dose of 3180 mg cashew protein
Time frame
T1 - One day after final day of maintenance treatmentSecondary outcomes
1
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in OIT vs placebo groups
Time frame
T2 - 8 weeks after final day of maintenance treatment2
The cumulative dose tolerated during the T1 challenge (cumulative doses below the reaction-eliciting dose if there is a reaction; or total cumulative challenge dose if there is no reaction) in OIT vs placebo groups
Time frame
T1 - One day after final day of maintenance treatment3
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in OIT vs placebo groups;
Time frame
T1 - One day after final day of maintenance treatment4
SPT wheal size to cashew (at the end of treatment, and at 8 weeks after end of treatment) in OIT vs placebo groups.
Time frame
T1 - One day after final day of maintenance treatmentSponsors and contacts
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Source ClinicalTrials.gov