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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2022-05-12

Brief Summary

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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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Detailed Description

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Conditions

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IgE Mediated Peanut Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desensitisation to peanut

Desensitisation using boiled peanut

Group Type EXPERIMENTAL

Desensitisation using boiled peanut

Intervention Type OTHER

Control

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).

Group Type EXPERIMENTAL

Desensitisation using boiled peanut (deferred start)

Intervention Type OTHER

Interventions

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Desensitisation using boiled peanut

Intervention Type OTHER

Desensitisation using boiled peanut (deferred start)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No