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
Qualifiers
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
Treatments tested in this trial
- Cashew oral immunotherapy
- Placebo oral immunotherapy
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov