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Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy — HILO  

Peanut Allergy Clinical Trial

Official title:
Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy

Clinical Trial Summary

This study will compare the effectiveness of three different treatments to treat peanut allergy

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06297083
Study type Interventional
Source Murdoch Childrens Research Institute
Contact Julie Burns, Study Coordinator
Phone +61399366184
Email hilo.study@mcri.edu.au
Status Not yet recruiting
Phase Phase 2
Start date April 2024
Completion date December 2027
View Details
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