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RECRUITING
NCT05503446
NA

Using Commonly Available Food Products To Treat Food Allergy

Sponsor: University of Southampton

View on ClinicalTrials.gov

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.

Official title: Using Commonly Available Food Products To Treat Food Allergy (NATASHA Study)

Key Details

Gender

All

Age Range

3 Years - 23 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2023-01-19

Completion Date

2026-08-31

Last Updated

2025-06-29

Healthy Volunteers

No

Interventions

OTHER

Peanut in common foods or supermarket-sourced cow's milk (CM)

Participants will be given a set dose of peanut (e.g. peanut-containing cereal, whole peanuts) or cow's milk to take on a daily basis, as per protocol

Locations (5)

University of Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Sheffield Children's Hospital NHS Foundation Trust

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom