NCT06297083

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	Peanut Oral Powder [PEANUT POWDER]	Peanut oral immunotherapy at varying doses and build-up regimes given daily for 18 months
DIETARY_SUPPLEMENT	Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin)	Probiotic or placebo-probiotic given daily for 18 months

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2024-03-06
• Last updated: 2024-09-19