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

Not Applicable

Completed

Interventions: Other: Desensitisation using boiled peanut
Other: Desensitisation using boiled peanut (deferred start)

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Desensitisation to peanut	Desensitisation using boiled peanut	Desensitisation using boiled peanut
Control	Desensitisation using boiled peanut (deferred start)	Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention).

Primary Outcome Measures

Name	Time	Method
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge	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 Outcome Measures

Name	Time	Method
Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT	After 1 year of OIT	Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
Study Compliance	12 months	Compliance with study protocol
Safety, Incidence of Adverse Event	12 months	Incidence of adverse allergic events during desensitisation protocol
Quality of Life Measures	6, 12 and 24 months	Quality of Life assessment and how this changes during peanut desensitisation.
Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT	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.
Immunological Outcomes	Pre, 3, 6, and 12 months post start of OIT	Immunological outcome measures pre-, during and post- 12 months of OIT

Locations (1): Imperial College London / Imperial College Healthcare NHS Trust
🇬🇧
London, United Kingdom

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