nctId: NCT06297083 id: 100992 briefTitle: Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy acronym: HILO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-03-06 date: 2024-04-08 name: Murdoch Childrens Research Institute class: OTHER briefSummary: This study will compare the effectiveness of three different treatments to treat peanut allergy conditions: Peanut Allergy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a three-arm, multi-center, head-to-head randomized study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 130 type: ESTIMATED name: Peanut Oral Powder [PEANUT POWDER] name: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin) measure: Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment. measure: Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment measure: Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE) measure: Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ). measure: Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size. measure: Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels measure: Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant measure: Difference between treatment arms in participant experience as assessed from qualitative interviews measure: Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) measure: 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) measure: Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment measure: Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment sex: ALL minimumAge: 1 Year maximumAge: 10 Years stdAges: CHILD facility: Womans and Childrens Hospital city: Adelaide state: South Australia zip: 5006 country: Australia name: Michael Gold role: CONTACT phone: +61881617000 email: Michael.gold@adelaide.edu.au lat: -34.92866 lon: 138.59863 facility: Murdoch Childrens Research Institute city: Melbourne state: Victoria zip: 3052 country: Australia name: Julie Burns role: CONTACT phone: +61399366184 email: hilo.study@mcri.edu.au lat: -37.814 lon: 144.96332 hasResults: False