Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

Exclusion Criteria

• •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
• •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 risks associated 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 conditions that 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 may affect the subject's ability to participate in the study e.g. increased risk to the participant
• •History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
• •Subjects who in the opinion of the Site Investigator are unable to follow the protocol NOTE: participants with other food allergies are NOT excluded from participating in this trial.