Using Commonly Available Food Products To Treat Food Allergy

Last updated: June 6, 2023
Sponsor: University of Southampton
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Allergies & Asthma

Allergy (Pediatric)

Treatment

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

Clinical Study ID

NCT05503446
ERGO 71012
IRAS ID 310316
  • Ages 3-23
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 6-23 years with IgE-mediated peanut allergy, or age 3-23 years with IgE-mediatedfood allergy to cow's milk
  2. Past history consistent with IgE-mediated allergy to the relevant allergen
  3. Allergic to cumulative ≤1.44 g protein (of the specific allergen) at baseline DBPCFC,prior to treatment allocation
  4. Written informed consent (for young people under 16, consent from the parent/legalguardian (AND assent from the young person when the young person is age 6+ years)

Exclusion

Exclusion Criteria:

  1. Required previous admission to an intensive care unit for management of an allergicreaction
  2. Clinically significant chronic illness (other than asthma, rhinitis or eczema)
  3. Moderate-severe eczema, defined as requiring more than once daily application of 1%hydrocortisone or equivalent topical calcineurin inhibitor as maintenance treatmentdespite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
  4. Poorly controlled asthma within the previous 3 months (as defined by clinicianjudgement with reference to the International Consensus On (ICON) Pediatric Asthmaconsensus), or asthma requiring treatment with >5 days oral corticosteroids within theprevious 3 months
  5. Previous history of eosinophilic oesophagitis
  6. Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and notyet established on maintenance dosing for at least 6 months
  7. Undergoing allergen immunotherapy for food allergy and within the first year oftreatment
  8. In CM-allergic children under consideration for desensitisation to CM:
  • currently consuming CM-containing products other than extensively-heated milk inbaked foods (e.g. biscuits, cakes)
  • significant symptoms of non-IgE-mediated CM allergy within the previous 12 months
  1. Taking prebiotic or probiotic supplements and unwillingness to discontinue
  2. Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker orAngiotensin Converting Enzyme (ACE) inhibitor
  3. Tolerance to cumulative ≥1.44 g food protein at initial DBPCFC during screening
  4. Objective allergic reaction to ≤4mg cow's milk protein or ½ Reese's puff inpeanut-allergic children, during screening
  5. Objective reaction to the placebo at screening DBPCFC
  6. Past or current medical issue, participation in another clinical trial or otherconsideration, which, in the opinion of the investigator, may pose additional risksfrom study participation, interfere with compliance or otherwise impact on the qualityor interpretation of study data
  7. Pregnancy
  8. Direct personal or commercial relationship with a member of the local study teamdirectly involved with the conduct of the trial
  9. Unwilling or unable to fulfil study requirements, including the requirement forappropriate supervision following dosing at home)

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Peanut in common foods or supermarket-sourced cow's milk (CM)
Phase:
Study Start date:
January 19, 2023
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • University of Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle,
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital NHS Foundation Trust

    Sheffield,
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton,
    United Kingdom

    Active - Recruiting

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