Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy
The Children’s Hospital of Westmead
National Health and Medical Research Council (NHMRC)
To determine whether graded peanut ingestion along with a dietary fibre supplement can train the body to become tolerant to peanut in children with peanut allergy.
Participants have daily, progressively increasing peanut protein doses and a daily fibre (either the highly butyrated starch or an inactive fibre to which they will be randomised and blinded), for 12 months. Interested children will undergo screening involving consent, a detailed history and examination, skin prick testing, quality of life questionnaires, lung function testing and an open food challenge to roasted soy (used in challenges). Participants enter the study after IgE-mediated peanut allergy is proven on food challenges which involves lung function, cannulation and blood tests. They are randomised to the control group (20% participants), or peanut oral immunotherapy with the butyrated (40%), or inactive (40%), fibre. Immunotherapy requires attendance to hospital 2-3 weekly to go up on dose of peanut protein. Immunotherapy and fibre will be stopped after 12 months. Controls will be contacted by phone monthly. All will have blood collected, skin prick tested and will complete a questionnaire on quality of life at the time of the first food challenge, then 3, 6, 12 and 13.5 months after randomisation. The ability to tolerate peanut will be assessed with food challenges 13.5 months after randomisation after a 6 week period of not eating the peanut or fibre. After completing the control year, all participants in the control group will be offered peanut immunotherapy and the butyrated fibre.
10-16 year olds that with an IgE-mediated peanut allergy proven by food challenge who give informed consent to participate. Participants cannot have a history of peanut anaphylaxis requiring admission to intensive care; chronic illnesses excluding asthma, eczema and hay fever; be in the first 12 months of immunotherapy for aero-allergens; on anti-IgE treatment; on immunosuppression medication; on beta-blockers or ACE inhibitors; react to less than 10mg or more than 1440mg in food challenge.
Recruitment completed, March 2020.
Study contact: [email protected]
Australia New Zealand Clinical Trials Registry: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12617000914369