Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

Inclusion Criteria:

• Aged between 3 year and 17 years of age;

• Either sex, and of any race and ethnicity;

• >7kg (the weight considered safe for the administration of an adrenalineautoinjector) (e.g. Jext);

• Confirmed diagnosis of cashew nut allergy as defined by a failed DBPCFC with cashewnut and a positive SPT (>=3mm than control) or sIgE to cashew nut (of at least 0.35kUA) at screening.

• Subject's parent and/ or guardian must be able to understand and provide informedconsent.

Exclusion Criteria:

• History of severe anaphylaxis (as defined by persistent hypotension, collapse, lossof consciousness, persistent hypoxia or ever needing more than three (3) doses ofintramuscular adrenaline or an intravenous adrenaline infusion for management of anallergic reaction)

• Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension,collapse, loss of consciousness, persistent hypoxia, or requiring more than 3 dosesof intramuscular adrenaline or an intravenous adrenaline infusion for management ofan allergic reaction)

• Any disorder in which adrenaline is contraindicated (such as hypertension or cardiacrhythm disorders)

• Reacting to the placebo component during the study entry DBPCFC

• FEV1 <85% at rest and FEV1/FVC ≤ 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)

• Underlying medical conditions (e.g. cardiac disease) that increase the risksassociated with anaphylaxis

• Use of beta-blockers, ACE inhibitors or calcium channel blockers

• Inflammatory intestinal conditions, indwelling catheters, gastrostomies,immune-compromised states, post-cardiac and/or gastrointestinal tract surgery,critically-ill and those requiring prolonged hospitalisation or other conditionsthat may increase the risks of probiotic associated sepsis

• Have received other food immunotherapy treatment in the preceding 6 months

• Currently taking immunomodulatory therapy (including allergen immunotherapy)

• Therapy with anti-IgE or other biologics within 1 year of enrolment

• Past or current major illness that in the opinion of the Site Investigator mayaffect the subject's ability to participate in the study e.g. increased risk to theparticipant

• History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)

• Subjects who in the opinion of the Site Investigator are unable to follow theprotocol NOTE: participants with other food allergies are NOT excluded fromparticipating in this trial.