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

Imperial College London47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgE Mediated Peanut Allergy

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: 12 months

Secondary Outcomes

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

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.

Time frame: 6 and 12 months after study intervention

Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT

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

Time frame: After 1 year of OIT

Safety, Incidence of Adverse Event

Incidence of adverse allergic events during desensitisation protocol

Time frame: 12 months

Quality of Life Measures

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

Time frame: 6, 12 and 24 months

Study Compliance

Compliance with study protocol

Time frame: 12 months

Immunological Outcomes

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes