The Grown Up Peanut Immunotherapy Study (GUPI)
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|ClinicalTrials.gov Identifier: NCT03648320|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Other: Peanut oral immunotherapy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults|
|Actual Study Start Date :||May 18, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Peanut oral immunotherapy
Desensitisation using peanut flour
Other: Peanut oral immunotherapy
Daily doses of peanut flour (with 2-weekly incremental interval)
- Desensitisation to 1.4g peanut [ Time Frame: 7-8 months ]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
- Desensitisation to 4.4g peanut [ Time Frame: 7-8 months ]Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT
- Incidence of adverse events related to treatment (safety) [ Time Frame: 7-8 months ]Incidence of local and systemic reactions during peanut OIT updosing and maintenance
- Reactions with ara h 8 sensitisation [ Time Frame: 7-8 months ]Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects.
- Skin prick test reactivity [ Time Frame: 9 months ]Change in size of wheal diameter to peanut extract following OIT
- Immunoglobulin G (IgG) levels [ Time Frame: 9 months ]Change in peanut-specific IgG following OIT
- Quality of life measure [ Time Frame: 7-8 months ]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'.
- Food Neophobia score [ Time Frame: 7-8 months ]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.
- Food Situations score [ Time Frame: 7-8 months ]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.
- Study compliance [ Time Frame: 7-8 months ]Compliance with OIT measured using monthly diaries.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648320
|Contact: Hannah Hunter, RD MSc||020 7188 0599||GUPI@gstt.nhs.uk|
|Contact: Kok Loong Ue, MBChB MRCP||020 7188 5846||GUPI@gstt.nhs.uk|
|Guy's and St Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE1 9RT|
|Contact: Hannah Hunter 020 7188 0599 GUPI@gstt.nhs.uk|
|Principal Investigator:||Stephen J Till, MA FRCP PhD||Guy's and St Thomas' NHS Foundation Trust / King's College London|