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NCT Number: NCT02149719

Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.

Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.

Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.

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Key information

Conditions

IgE Mediated Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London / Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
  • Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
  • Informed consent of parent/legal guardian and patient assent

Exclusion criteria

  • Allergic to 1/4 boiled peanut at PCFC
  • Tolerates ≥1.4 g roasted peanut protein at entry PCFC
  • Unstable asthma
  • Unwilling or unable to fulfil study requirements
  • Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
  • Previous admission to ICU for management of allergic reaction to peanut
  • Clinically significant chronic illness (other than asthma, rhinitis or eczema).
  • Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
  • Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.

Treatment and study plan

Desensitisation using boiled peanut

Other

Desensitisation using boiled peanut (deferred start)

Other

Primary outcomes

  1. Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge

    Time frame: 12 months

    The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.

Secondary outcomes

  1. Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT

    Time frame: 6 and 12 months after study intervention

    Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months.

  2. Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT

    Time frame: After 1 year of OIT

    Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.

  3. Safety, Incidence of Adverse Event

    Time frame: 12 months

    Incidence of adverse allergic events during desensitisation protocol

  4. Quality of Life Measures

    Time frame: 6, 12 and 24 months

    Quality of Life assessment and how this changes during peanut desensitisation.

  5. Study Compliance

    Time frame: 12 months

    Compliance with study protocol

  6. Immunological Outcomes

    Time frame: Pre, 3, 6, and 12 months post start of OIT

    Immunological outcome measures pre-, during and post- 12 months of OIT

Other outcomes

  1. Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline

    Time frame: 12 months

    Change in threshold in peanut-allergic subjects found to be tolerant to boiled peanut at baseline, as determined by double-blind, placebo-controlled food challenges pre- and post- desensitisation.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • University of Sydney

Registry information

Official study title

Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy

Acronym: BOPI-1

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
May 29, 2014
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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