protocolSection identificationModule nctId: NCT06297083, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: This study will compare the effectiveness of three different treatments to treat peanut allergy, conditionsModule conditions: Peanut Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a three-arm, multi-center, head-to-head randomized study, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Peanut Oral Powder [PEANUT POWDER], interventions name: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin), outcomesModule primaryOutcomes measure: Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment., secondaryOutcomes measure: Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment, secondaryOutcomes measure: Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE), secondaryOutcomes measure: Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ)., secondaryOutcomes measure: Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size., secondaryOutcomes measure: Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels, secondaryOutcomes measure: Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant, secondaryOutcomes measure: Difference between treatment arms in participant experience as assessed from qualitative interviews, secondaryOutcomes measure: Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), secondaryOutcomes 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), secondaryOutcomes measure: Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment, secondaryOutcomes measure: Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Womans and Childrens Hospital, city: Adelaide, state: South Australia, zip: 5006, country: Australia, contacts name: Michael Gold, role: CONTACT, phone: +61881617000, email: Michael.gold@adelaide.edu.au, geoPoint lat: -34.92866, lon: 138.59863, locations facility: Murdoch Childrens Research Institute, city: Melbourne, state: Victoria, zip: 3052, country: Australia, contacts name: Julie Burns, role: CONTACT, phone: +61399366184, email: hilo.study@mcri.edu.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False