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Peanut allergy affects 1 in 30 UK children, and is the commonest cause of life-threatening allergic reactions (anaphylaxis) in this age group. Oral immunotherapy (OIT) is an emerging treatment, where small, increasing doses of allergen are used to cause “desensitisation”. However, mild allergic reactions (and occasionally, anaphylaxis) are frequent side effects, and are a limiting factor: up to 20% of participants are unable to tolerate the treatment. Furthermore, unless regular OIT doses are continued once desensitisation has been achieved, the effect is lost: fewer than 1 in 3 maintain “sustained unresponsiveness” (SU, often referred to as “tolerance”) after stopping OIT.
Immunotherapy is widely undertaken for the treatment of hay fever and allergy to insect stings, and the success of treatment is dependent on the duration of immunotherapy. We expect therefore that for food allergy, the duration of OIT may be of critical importance for achieving SU.
In the Boiled Oral Peanut Immunotherapy (BOPI) study (NCT02149719), we used boiled peanut (which is less allergenic than roasted peanut) to successfully induce desensitization, with over 50% demonstrating SU after stopping all peanut doses for 4 weeks.
We now wish to conduct a study to demonstrate that boiled peanut is at least as effective as roasted peanut flour in treating children with peanut allergy. We propose a head-head comparison of boiled peanut to peanut flour for OIT. We will also compare results to the original BOPI study, allowing us to evaluate how duration of treatment impacts upon clinical efficacy after stopping treatment. This will inform:
• as to whether ad libitum peanut consumption is feasible after OIT – arguably the most important outcome for allergic individuals and their families
• provide a unique data set relating to duration of OIT and treatment success,
• identify predictive factors to personalise OIT protocols, maximizing successful and safe patient outcomes.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Dietary;Immunotherapy;
You can take part if:
You may not be able to take part if:
1. Required previous admission to an intensive care unit for management of an allergic reaction to peanut. 2. Clinically significant chronic illness (other than asthma, rhinitis or eczema). 3. Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 3 months. 4. Undergoing oral immunotherapy for food allergy and within the first year of treatment. 5. Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor. 6. Clinical allergy to either soya or sunflower seed 7. Tolerance to > = 1.44 g peanut protein (approx. 6 peanuts) at initial DBPCFC during screening. 8. Dose-limiting symptoms to 1/8 boiled peanut (boiled for 4 hours) at screening. 9. Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus ), or asthma requiring treatment with > 5 days oral corticosteroids within the previous 3 months. 10. Pregnancy 11. Unwilling or unable to fulfil study requirements
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by Medical Research Council (MRC); Academic Health Science Network: Imperial College Health Partners; .
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for Trial ID: CPMS 41327
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