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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 23
Healthy Volunteers: f
View:

• Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediated food allergy to cow's milk

• Past history consistent with IgE-mediated allergy to the relevant allergen

• Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC, prior to treatment allocation

• Written informed consent (for young people under 16, consent from the parent/legal guardian (AND assent from the young person when the young person is age 6+ years)

Locations
Other Locations
United Kingdom
University of Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Imperial College Healthcare NHS Trust
RECRUITING
London
Newcastle upon Tyne Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Newcastle
Sheffield Children's Hospital NHS Foundation Trust
RECRUITING
Sheffield
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Hasan Arshad, MBBS DM FRCP
p.turner@imperial.ac.uk
44 23 8120 5232
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 216
Treatments
Experimental: Oral Immunotherapy, in-hospital supervision for updosing
Active oral immunotherapy, with all updosing visits taking place in hospital
Experimental: Oral Immunotherapy, virtual supervision for updosing
Active oral immunotherapy, with all updosing visits taking place with virtual supervision
No_intervention: Control arm: allergen avoidance
Related Therapeutic Areas
Sponsors
Leads: University of Southampton
Collaborators: Imperial College London, Natasha Allergy Research Foundation

This content was sourced from clinicaltrials.gov