*This page is for general information only. If you are interested in participating in this study, please visit the OPIA study website for more information.*
Study short name: OPIA
Study full name: Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy
Principle Investigator: Peter Hsu
Administering Institute: The Children's Hospital of Westmead
Major funding source: National Health and Medical Research Council (NHMRC)
Study focus: Treatment
Study design: Intervention
Main study aim: 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.
Additional study information: 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.
Study population: 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.
Study status: Recruitment completed, March 2020.
Where can I find more information?
Australia New Zealand Clinical Trials Registry: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12617000914369
Study contact: [email protected]
Last modified: March 3rd 2020 | Date created: April 9th 2019