None listed
Conditions
Brief summary
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. Little is known about tree nut allergy. Current allergy testing methods are indicative of IgE sensitisation only and are not diagnostic of food allergy. Current practice at RCH allergy clinic in children who are egg and/or peanut allergic is to advise families to introduce each individual tree nut into their child’s diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of this strategy has not been formally evaluated. This pilot study is a 2-armed, open-label, randomised, controlled trial (RCT) to assess the safety and feasibility of a supervised hospital based multi-tree nut oral food challenge (OFC) versus standard care (home introduction of individual tree nuts) in infants with egg and/or peanut allergy to reduce the risk of developing tree nut allergy.
Interventions
Multiple tree nut (cashew, almond, walnut, hazelnut) in hospital oral food challenge. Prepared by specialised allergy dietitian and administered by an allergy trained nurse and supervised by an allergist. Total dose is 20g delivered in a carrier food of the participants choice (ie fruit puree, yogurt, custard, bread, crackers) over 6 doses in a 4 hour period:
Smear, 1/8 teaspoon, ¼ teaspoon, ½ teaspoon, 1 teaspoon, approx. 2 teaspoons (remainder of dose). Total challenge dose of 20g of nut prote
Multiple tree nut (cashew, almond, walnut, hazelnut) in hospital oral food challenge. Prepared by specialised allergy dietitian and administered by an allergy trained nurse and supervised by an allergist. Total dose is 20g delivered in a carrier food of the participants choice (ie fruit puree, yogurt, custard, bread, crackers) over 6 doses in a 4 hour period: Smear, 1/8 teaspoon, ¼ teaspoon, ½ teaspoon, 1 teaspoon, approx. 2 teaspoons (remainder of dose). Total challenge dose of 20g of nut protein (approx 4 teaspoons)
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Months to 11 Months
Healthy volunteers
No
Inclusion criteria
- Infants >4mths and less than 11mths of age currently referred to the Royal Children's Hospital Allergy Department. - History of likely IgE-mediated egg and/or peanut reaction as determined by RCH allergist with positive skin prick test to egg and/or peanut (>=3mm) - Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
Exclusion criteria
- any history of food induced anaphylaxis - pre existing tree nut allergy - any tree nut already tolerated (ingestion on >3 occasions without reaction) - unable to eat solid food - inability or unwillingness of participant or legally acceptable representative to give written informed consent.
Outcome results
None listed