TRACE mechanistic assessments

  • Research type

    Research Study

  • Full title

    Mechanisms underlying the change in threshold or severity of peanut allergic reaction in TRACE peanut study participants

  • IRAS ID

    172382

  • Contact name

    Paul Turner

  • Contact email

    p.turner@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Clinicaltrials.gov Identifier

    NCT01429896

  • Duration of Study in the UK

    3 years, 6 months, 0 days

  • Research summary

    Food allergy affects up to 2% of adults and 8% of children in the UK. It is the commonest cause of life-threatening allergic reactions, and significantly impairs quality of life due to anxiety over the potential for severe reactions (anaphylaxis) and the practicalities of allergen avoidance. Little is known about what actually happens during a food-allergic reaction, and why some people experience only mild symtpoms to large doses of food allergen, while others can have fatal anaphylaxis to tiny amounts.

    The work proposed in this application takes full advantage of an existing study which assesses the amount of peanut needed to trigger a reaction in peanut allergic adults (Threshold Reaction and Clinical Evaluation (TRACE) Peanut Study). TRACE involves repeated food challenges of peanut-allergic adults under strict medical supervision. The trial (Clinical Trials.Gov number: NCT01429896) has been commissioned by the Food Standards Agency (FSA) to determine the threshold or “Minimum Eliciting Dose” required to trigger a reaction in peanut-allergic adults, and how this is affected by exercise and sleep deprivation.

    We plan to study these allergic reactions in more detail, using a range of non-invasive testing and collection of biological samples, to learn more about the processes causing symptoms during food allergic reactions and how these vary between individuals.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    15/LO/0286

  • Date of REC Opinion

    3 Mar 2015

  • REC opinion

    Favourable Opinion