PPOIT-1: Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (OIT) in inducing desensitisation or tolerance in children with peanut allergy
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 | Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (OIT) in inducing desensitisation or tolerance in children with peanut allergy |
| Study abbreviation | PPOIT-1 |
| Current principal investigator/s | Prof Mimi Tang |
| 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 | The Royal Children’s Hospital, Murdoch Childrens Research Institute |
| Major funding sources | National Health and Medical Research Council (NHMRC); Murdoch Childrens Research Institute; Food Allergy and Anaphylaxis Network (FAAN); Perpetual Philanthropy; The Contributing to Australian Scholarship and Science (CASS) Foundation; Financial Markets Foundation for Children |
| Study website | http://foodallergyresearch.org.au/research/clinical/ |
| Key reference | Tang, M.L., Ponsonby, A.-L., Orsini, F., Tey, D., Robinson, M., Su, E.L., Licciardi, P., Burks, W. and Donath, S. (2015). Administration of a probiotic with peanut oral immunotherapy: A randomized trial. J Allergy Clin Immunol. 135(3): 737-44.e8. doi: 10.1016/j.jaci.2014.11.034 |
| 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 rhamnosus and peanut OIT to induce sustained unresponsiveness to peanut, in other words, a possible effective treatment for peanut allergy. |
| Sampling frame | Participants were recruited between December 2008 and March 2011 from the Royal Children’s Hospital (Melbourne, Australia) Department of Allergy and Immunology outpatient clinics and through print media. |
| Year commenced | 2008 |
| Commencement sample | 62 (31 PPOIT, 31 placebo) |
| Intergenerational? | No |
| Imaging | No |
| Linkage | No |
| Biosamples? | Blood, faeces, saliva, posterior palatal swab, rectal swab (or faecal sample) |
| Ethics approvals or requirements? | This project only (Specific consent) |
Waves
| Wave | Year | Age (mean, range) | Eligible sample |
|---|---|---|---|
| 1 | 2008 – 2011 (Randomisation/RUSH day) | PPOIT: 6.1 (SD 2.4); Placebo: 5.8 (SD 2.6) | PPOIT: 31; Placebo: 31 |
| 2 | 2008 – 2011 (Build-up) | Baseline + 1 – 8 months | NA |
| 3 | 2009 – 2013 (Maintenance) | Baseline + 9 – 18 months | NA |
| 4 | 2010 – 2013 (Week 78+ T1 DBPCFC) | Baseline + ≥ 18 months | PPOIT: 29; Placebo: 28 |
| 5 | 2010 – 2013 (Post treatment 1) | Baseline + ≥ 18.5 months | PPOIT: 28; Placebo: 28 |
| 6 | 2010 – 2013 (Post treatment 2) | Baseline + ≥ 21 months | PPOIT: 28; Placebo: 28 |
| 7 | 2010 – 2013 (Post treatment 3) | Baseline + ≥ 24 months | |
| 8 | 2011 – 2014 (Post treatment 4) | Baseline + ≥ 30 months | |
| 9 | 2013 – 2016 (Post treatment 5) | Baseline + 54 – 66 months | PPOIT: 24; Placebo: 24 |
| 10 | 2013 – 2019 (6 monthly follow ups) | Baseline + 60 – 96 months | PPOIT: 24; Placebo: 24 |
| 11 | 2016 – 2019 (Final follow up) | Baseline + 90 – 102 months | PPOIT: 24; Placebo: 24 |