Synopsis

The prevalence of food allergy has increased, particularly in westernised countries. The need for a curative treatment is greatest for peanut allergy because this is usually life-long and the most common cause of anaphylaxis-related fatality. Oral immunotherapy (OIT) has been explored as a strategy to induce tolerance to food allergens. The PPOIT (probiotic and peanut oral immunotherapy) trials are a series of studies investigating the use of the probiotic Lactobacillus rhamnosus and peanut OIT to induce sustained unresponsiveness to peanut, in other words, a possible effective treatment for peanut allergy. The inclusion of a probiotic has been postulated to enhance the tolerogenic effect of OIT.

PPOIT-1 – a double-blind, placebo-controlled randomised trial to determine the effectiveness of PPOIT therapy in children with clinically proven peanut allergy. 62 children aged 1-10 years were recruited (31 to receive PPOIT, 31 placebo) from December 2008 to March 2011.

PPOIT-2 – an open trial. After PPOIT-1 demonstrated that PPOIT successfully induces sustained unresponsiveness to peanut, PPOIT-2 trialled a shorter treatment schedule of PPOIT in children with clinically proven peanut allergy. 20 children aged 1-12 years were recruited from December 2015 to February 2016.

PPOIT-3 – a phase 3, multi-centre, 3 arm randomised controlled trial evaluating the effectiveness of PPOIT in inducing sustained unresponsiveness in children with clinically proven peanut allergy compared with peanut oral immunotherapy alone and with placebo. Approximately 200 children aged 1-10 years will be recruited, 80 for each of the probiotic and peanut OIT and peanut OIT only groups, and 40 for the placebo group. Recruitment began in July 2016.

Summary

 

Study name A phase 3, multicentre, randomised, controlled trial evaluating the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with placebo.
Study abbreviation PPOIT-3
Current principal investigator/s Dr Paxton Loke
Current project manager Ms Christine Axelrad
Cohort representative (study contact) Ms Christine Axelrad
Postal address Allergy and Immune Disorders
Murdoch Children’s Research Institute
Flemington Rd
Parkville, Victoria 3052
Australia
Phone +613 9345 6974
Email Christine.Axelrad@rch.org.au
Primary Institution Royal Children’s Hospital, Murdoch Children’s Research Institute
Collaborating Institution/s Women and Children’s Hospital Adelaide
Perth Children’s Hospital / Princess Margaret Hospital
Major funding sources National Health and Medical Research Council (NHMRC)
Murdoch Children’s Research Institute
Study website anzctr.org.au/Trial/Registration
Are data available outside study team? No, not at this time
Study focus The PPOIT (probiotic and peanut oral immunotherapy) trials are a series of studies investigating the use of the probiotic Lactobacillus rhamnosusand peanut OIT to induce sustained unresponsiveness to peanut, in other words, a possible effective treatment for peanut allergy.
Sampling frame Participants will be recruited from Allergy departments at three tertiary paediatric hospitals in Australia, and from the general community reached by media.
The three sites are:
1. The Royal Children’s Hospital Melbourne / Murdoch Children’s Research Institute (RCH/MCRI)
2. The Women’s and Children’s Hospital Adelaide (WCH)
3. Perth Children’s Hospital (PCH) / Princess Margaret Hospital
Year commenced 2016
Target sample 200, 80 PPOIT, 80 OIT only, 40 placebo
Intergenerational? No
Imaging No 
Linkage Access to medical records
Biosamples? Blood, faeces
Ethics approvals or requirements? This project only (Specific consent)

 

Waves

Wave Year Age (mean, range) Eligible sample
1  2016 – 2017 (Screening)   Ongoing
2  2016 – 2017 (RUSH)   Ongoing
3  2016 – 2017 (Build-up)  Baseline + 1 – 4 months Ongoing
4  ~ 2016 – 2018 (Maintenance)  Baseline + 5 – 18 months  Planned
5  ~ 2018 (T1 – final day of treatment)  Baseline + 18 months  Planned
6  ~ 2018 (T2 – 12 weeks after final day of treatment)  Baseline + 21 months  Planned
7  ~ 2018 – 2019 (6 months after final day of treatment)  Baseline + 24 months Planned 
8  ~ 2019 (T3 – 1 year after final day of treatment)  Baseline + 30 months  Planned