PPOIT-3: 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.
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 | Julie Burns |
| Cohort representative (study contact) | Julie Burns |
| Postal address | Allergy Immunology, Murdoch Children’s Research Institute, Flemington Rd, Parkville, Victoria 3052 |
| Phone | +613 9345 6974 |
| Julie.burns@mcri.edu.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) | 248 | |
| 2 | 2016 – 2017 (RUSH) | 5.9 (1-10) | 201 |
| 3 | ~ 2018 (T1 – final day of treatment) | Baseline + 18 months | 178 |
| 4 | ~ 2018 (T2 – 8 weeks after final day of treatment) | Baseline + 20 months | 176 |
| 5 | ~ 2019 (T3 – 1 year after final day of treatment) | Baseline + 30 months | 175 |