Using Commonly Available Food Products To Treat Food Allergy

NCT05503446 | Recruiting DMC

• 2 other identifiers: ERGO 71012IRAS ID 310316
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

IgE-Mediated Cow Milk Allergy; Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• Efficacy and effectiveness

  The proportion of participants in intervention arms (combined) versus control arm (by allergen) who, following 9-12 months of OIT (or standard care, for controls): * tolerate at least 1 gram of food protein (discrete dose, approximately 4-6 peanuts, or 30ml of CM) AND * demonstrate a minimum 10-fold increase in the maximum tolerated dose (defined as the highest dose not causing dose-limiting symptoms) at the end-of-updosing double-blind, placebo-controlled food challenge (DBPCFC), compared to baseline DBPCFC

  9-12 months

Secondary Outcomes (8)

• Safety: adverse events

  24 months

• Health-related quality of life (HRQL) as assessed by the Food Allergy Quality of Life Questionnaire (FAQLQ)

  24 months

• Health-related quality of life (HRQL) as assessed by EQ5D

  24 months

• Health-related quality of life (HRQL) as CHU9D

  24 months

• Adherence to dietary avoidance

  24 months

Study Arms (3)

Oral Immunotherapy, in-hospital supervision for updosing

EXPERIMENTAL

Active oral immunotherapy, with all updosing visits taking place in hospital

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

Oral Immunotherapy, virtual supervision for updosing

EXPERIMENTAL

Active oral immunotherapy, with all updosing visits taking place with virtual supervision

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

Control arm: allergen avoidance

NO INTERVENTION

Interventions

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

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

Oral Immunotherapy, in-hospital supervision for updosing; Oral Immunotherapy, virtual supervision for updosing

Eligibility Criteria

• Age: 3 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Required previous admission to an intensive care unit for management of an allergic reaction
• Clinically significant chronic illness (other than asthma, rhinitis or eczema)
• Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the International Consensus On (ICON) Pediatric Asthma consensus), or asthma requiring treatment with \>5 days oral corticosteroids within the previous 3 months
• Previous history of eosinophilic oesophagitis
• Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 6 months
• Undergoing allergen immunotherapy for food allergy and within the first year of treatment
• In CM-allergic children under consideration for desensitisation to CM:
• currently consuming CM-containing products other than extensively-heated milk in baked foods (e.g. biscuits, cakes)
• significant symptoms of non-IgE-mediated CM allergy within the previous 12 months
• Taking prebiotic or probiotic supplements and unwillingness to discontinue
• Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or Angiotensin Converting Enzyme (ACE) inhibitor
• Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening
• Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff in peanut-allergic children, during screening
• Objective reaction to the placebo at screening DBPCFC
• Past or current medical issue, participation in another clinical trial or other consideration, which, in the opinion of the investigator, may pose additional risks from study participation, interfere with compliance or otherwise impact on the quality or interpretation of study data

Sponsors & Collaborators

• University of Southampton: lead
• Imperial College London: collaborator
• Natasha Allergy Research Foundation: collaborator

Study Sites (5)

University of Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

RECRUITING

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

NOT YET RECRUITING

Sheffield Children's Hospital NHS Foundation Trust

Sheffield, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Paul J Turner, FRCPCH PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Arshad, MBBS DM FRCP

CONTACT

44 23 8120 5232; p.turner@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessed by double-blind, placebo-controlled food challenge
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm, with cross-over for those allocated to control group only following determination of primary outcome

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 16, 2022
• Study Start: January 19, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)