This study will compare the effectiveness of three different treatments to treat peanut allergy
This is a three-arm, multi-centre, head-to-head randomised trial, comparing two treatments against a low dose oral immunotherapy approach for peanut allergy. One hundred and thirty children aged 1 year to 10 years with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited for this study. Participants will be recruited from The Royal Children's Hospital Melbourne, Women's and Children's Hospital (Adelaide) and from the general community. Participants will be randomized to: 1. High-dose rapid escalation peanut OIT combined with probiotic (HD PPOIT) 2. High-dose rapid escalation peanut OIT combined with probiotic placebo (HD OIT) 3. Low-dose slow escalation peanut OIT combined with probiotic placebo (LD OIT) The length of the treatment period for each participant is 18 months and the post-treatment follow up period is 12 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Peanut oral immunotherapy at varying doses and build-up regimes given daily for 18 months
Probiotic or placebo-probiotic given daily for 18 months
Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment.
Remission will be assessed 8 weeks after the end of treatment timepoint and is defined as passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) at the end of treatment and at 8 weeks post treatment
Time frame: 22 months
Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment
Full desensitisation will be defined by participants passing (completing without reaction) the double-blind placebo controlled food challenge (DBPCFC) undertaken at the end of treatment
Time frame: 20 months
Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE)
The total number of treatment-related AE the participant reports during the course of treatment adjusted for the time the participant is on treatment (in years)
Time frame: 20 months
Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ).
FAQLQ total score, as well as three sub-scores (food anxiety, general emotional impact, and social and dietary limitations) will be calculated as per the instrument scoring manual
Time frame: Baseline, 22weeks, 76 weeks, 84 weeks, 128 weeks
Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size.
Skin prick test to whole peanut extract
Time frame: Baseline, 76 weeks, 84 weeks,128 weeks
Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels
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Blood samples will be collected and levels of sIgE against peanut will be measured by ImmunoCAP (Phadia AB, Uppsala, Sweden)
Time frame: Baseline, 76 weeks, 84 weeks,128 weeks
Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant
Adherence to treatment will be monitored by reviewing the participant diary
Time frame: 20 months
Difference between treatment arms in participant experience as assessed from qualitative interviews
Interview guide developed and conducted, recorded, transcribed verbatim, and responses explored using framework analysis
Time frame: 20 months
Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)
Captured per number of hospitalizations, Emergency room (ER) visits, General Practitioner (GP) visits and medications / number of prescriptions required. Data acquired using participant questionnaires, participant study diaries and supplemented by administrative hospital data linkage
Time frame: Baseline through to 32 months
Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D)
Time frame: 32 months
Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment
Peanut ingestion data will be captured from the participant's study diary
Time frame: 20 months to 32 months
Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment
Number of reactions, symptoms experienced, and treatment administered will be captured from the participant's study diary
Time frame: 20 months to 32 months