Clinical Trial

Using Commonly Available Food Products To Treat Food Allergy

Study acronym: NATASHA
Active, Not Recruiting
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Summary
Food allergy affects 1 in 30 children, and is the commonest trigger for life-threatening reactions (anaphylaxis) in this age group. It is a major public health issue, with practical implications for industry, education and healthcare systems. Oral immunotherapy (OIT) is an emerging treatment option, where small, increasing doses of a food allergen are used to cause "desensitisation", so food-allergic individuals no longer have symptoms when exposed to the trigger food. However, frequent allergic reactions during OIT (including anaphylaxis) are common, and can lead to patients having to stop treatment. In addition, food-allergic children usually dislike the taste of the food they are allergic too, which affects compliance and treatment success. There is a lack of longer-term data to inform cost-effectiveness analyses for OIT. The NATASHA study will recruit young people from age 6+ years with IgE-mediated peanut allergy, and young people aged 3+ years with IgE-mediated allergy to cow's milk, who will undergo oral immunotherapy for these allergens using real-world foods (taken carefully according to a standardised protocol under medical supervision). In addition to assessing efficacy and safety outcomes, we will also collect longer-term data to evaluate cost-effectiveness in the UK setting.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-08-12; most recent amendment 2026-05-08.
Status change: Recruiting → Active, Not Recruiting 2026-05-08
Status change: Not Yet Recruiting → Recruiting 2023-06-06
Trial Details
NCT Number NCT05503446
Lead Sponsor University of Southampton
Collaborators: Imperial College London, Natasha Allergy Research Foundation
Conditions IgE-Mediated Cow Milk Allergy, Peanut Allergy
Enrollment 216 participants
Start Date 2023-01-19
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-13