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Pragmatic Low-Dose Oral Immunotherapy for Preschool Children With Peanut Allergy: A Randomised Controlled Trial
Michael O'Sullivan1,2,3, Rachael Wallace1, Samantha Thomas1
1Immunology Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.
Insights
Peanut oral immunotherapy (OIT) effectively desensitizes young children to peanut protein after 12 months, significantly improving their quality of life compared to avoidance. This study demonstrates OIT
Area of Science:
- Pediatric Allergy and Immunology
- Food Allergy Research
- Clinical Trial Design
Background:
- Peanut allergy is a prevalent and persistent childhood food allergy.
- Peanut oral immunotherapy (OIT) is a promising treatment, but its efficacy with parent-measured doses in young children requires further investigation.
- Few studies compare peanut OIT with standard avoidance protocols in this age group.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of a pragmatic peanut OIT protocol in children aged 1-4 years.
- To compare parent-measured OIT doses with a low maintenance dose against peanut avoidance.
- To assess desensitization, adverse events, quality of life, and immunological markers.
Main Methods:
- An unblinded randomized controlled trial involving 54 children aged 1-4 years.
- Participants were assigned to either peanut OIT (360 mg maintenance dose) or peanut avoidance for 12 months.
- Primary outcome was desensitization, defined by tolerating ≥600 mg peanut protein in an end-of-treatment oral food challenge.
Main Results:
- 74% of OIT participants tolerated ≥600 mg peanut protein versus 11% in the avoidance group.
- 41% of OIT participants passed the end-of-treatment challenge, compared to 7% in the avoidance group.
- The OIT group showed significantly improved quality of life (p=0.041).
Conclusions:
- Peanut OIT with parent-measured doses and a 360 mg maintenance dose effectively induces desensitization in 1-4 year olds after 12 months.
- Peanut OIT offers improved quality of life compared to avoidance in this cohort.
- The studied peanut OIT protocol demonstrates an acceptable safety profile.
Introduction:
Peanut allergy is the most common childhood-onset, persistent food allergy. Peanut oral immunotherapy (OIT) is a potential treatment, but few studies prospectively examine the outcome of peanut OIT in young children using parent-measured doses compared to standard care (peanut avoidance).
Objective:
To determine the efficacy, safety and tolerability of a pragmatic peanut OIT protocol (parent-measured doses with low maintenance dose) compared to avoidance.
Methods:
In this unblinded randomised controlled trial (1:1 ratio), children 1-4 years old were assigned to receive peanut OIT (maintenance dose 360 mg) or avoidance for 12 months. The primary outcome was desensitisation, defined as the ability to tolerate at least 600 mg peanut protein during an end-of-treatment oral food challenge (EOT OFC), with secondary outcomes frequency and severity of adverse events, change in quality of life and change in immunological markers of peanut allergy.
Results:
A total of 54 children were randomised, with 23/27 in the peanut OIT and 25/27 in the avoidance group undergoing open peanut challenge after 12 months. An eliciting dose of ≥ 600 mg peanut protein was tolerated by 74% (20/27) of OIT compared to 11% (3/27) of avoidance participants. 41% of OIT (11/27) and 7% of avoidance (2/27) participants passed the end-of-treatment challenge. The OIT group reported significantly better quality of life than the avoidance group after 12 months (Food Allergy Quality of Life Questionnaire-Parent Form mean difference -0.5, p = 0.041). There were 79 treatment-related adverse events reported by 21 participants in the OIT group (median 2 per participant, range 0-13).
Conclusion:
Peanut OIT using parent-measured doses and a low maintenance dose of 360 mg is effective at inducing desensitisation after 12 months in 1- to 4-year-old children. In this cohort, peanut OIT is associated with improved quality of life compared to avoidance and appears to have an acceptable safety profile.
Trial Registration:
Australian New Zealand Clinical Trials Registry: ACTRN12621001001886 (registered 30 July 2021).
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