To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.
25 adults with peanut allergy, as confirmed by double blind placebo controlled food challenge (DBPCFC), will undergo peanut oral immunotherapy (OIT) with peanut flour. An additional 15 untreated peanut allergic adults will be recruited as comparator group for skin prick tests and mechanistic studies/immunological assays.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Daily doses of peanut flour (with 2-weekly incremental interval)
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Desensitisation to 1.4g peanut
Tolerance of cumulative dose of 1.4g peanut protein without reaction on DBPCFC post OIT after minimum of 1 month maintenance dosing on peanut OIT
Time frame: 7-8 months
Desensitisation to 4.4g peanut
Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT
Time frame: 7-8 months
Incidence of adverse events related to treatment (safety)
Incidence of local and systemic reactions during peanut OIT updosing and maintenance
Time frame: 7-8 months
Reactions with ara h 8 sensitisation
Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.
Time frame: 7-8 months
Skin prick test reactivity
Change in size of wheal diameter to peanut extract following OIT
Time frame: 9 months
Immunoglobulin G (IgG) levels
Change in peanut-specific IgG following OIT
Time frame: 9 months
Quality of life measure
Change measured using Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF) and the Food Allergy Independent Measure Adult Form (FAIM-AF). These are validated questionnaires consisting of 29 (FAQLQ-AF) and 6 (FAIM-AF) questions each scored on a 7 point likert scale. The total scores are the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'.
Time frame: 7-8 months
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Food Neophobia score
Change measured using validated Food Neophobia Scale (FNS) questionnaire. This consists of 8 questions with answers on a 7 point likert scale ranging from 1 ("disagree strongly") to 7 ("agree strongly"). The total score is the mean score of all questions with lower score signifying increased food neophobia.
Time frame: 7-8 months
Food Situations score
Change using Food Situations Questionnaire, validated in children and amended to be appropriate for adults. 10 different scenarios related to food are rated from 1 (very unhappy) to 5 (very happy), giving a total possible score of 50. Higher scores are indicative of lower food neophobia.
Time frame: 7-8 months
Study compliance
Compliance with OIT measured using monthly diaries.
Time frame: 7-8 months