Probiotic and Peanut Oral Immunotherapy Studies (PPOIT)
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.
| Study Summary | |
|---|---|
| Study name | Probiotic and Peanut Oral Immunotherapy Studies |
| Study abbreviation | PPOIT |
| Current principal investigator/s |
Mimi Tang Paxton Loke |
| Current project manager |
Julie Burns |
| Primary Institution/s |
The Royal Children’s Hospital - RCH
Murdoch Children’s Research Institute - MCRI |
| Collaborating Institution/s |
Perth Children’s Hospital - including Princess Margaret Hospital for Children Women and Children’s Hospital Adelaide |
| Major funding source/s |
National Health and Medical Research Council - NHMRC
Murdoch Children’s Research Institute - MCRI Food Allergy and Anaphylaxis Network - FAAN |
| Study website | https://www.foodallergyresearch.org.au/researchers/food-allergy-studies/ppoit-003/ |
| Key reference for study | 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 |
| 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 |
Children with clinically proven peanut allergy were recruited through the Royal Children’s Hospital (Melbourne) Department of Allergy/Murdoch Children's Research Institute (RCH/MCRI), also through Immunology outpatient clinics and the general community through media. For PPOIT-3, participants were also recruited from the Women’s and Children’s Hospital Adelaide and Perth Children’s Hospital / Princess Margaret Hospital. |
| Primary study type | Randomised Control Trial / Other trial |
| Year commenced |
2008 |
| Is this study ongoing? | Yes - the study is ongoing |
| Ongoing recruitment? | No |
| Sample size (N) |
PPOIT-1: 62; PPOIT-2: 20; PPOIT-3: 201; PPOIT-3LT: 151. |
| Survey data available? | Yes |
| Imaging data available? | No |
| Linkage to administrative dataset/s? | Yes, linkage to (at least one) administrative dataset underway |
| Biosamples available? | Yes |
| Are data available to others outside study team, with appropriate safeguards and structures in line with the cohort’s ethics and governance processes? | No |
| Are there any costs associated with data/sample access for approved requests? | There may be costs associated with access, evaluated on a case by case basis |
| Broadest type of participant consent available |
Specific consent (can be used for this project only) |
2022
Ashley SE, Jones AC, Anderson D, Holt PG, Bosco A, Tang MLK. (2022). Remission of peanut allergy is associated with rewiring of allergen-driven T helper 2-related gene networks. Allergy, 77(10), 3015 - 3027. DOI: 10.1111/all.15324
Hsiao K-C, Ponsonby A-L, Ashley S, Lee CYY, Jindal L, PPOIT Study Team , Masters of advanced practice nursing , Tang MLK. (2022). Longitudinal antibody responses to peanut following probiotic and peanut oral immunotherapy (PPOIT) in children with peanut allergy. Clin Exp Allergy. DOI: 10.1111/cea.14146
2021
Dunn Galvin A, Lloyd M, Hsiao K-C, Tang MLK, PPOIT-001 study team . (2021). Long-term benefit of probiotic peanut oral immunotherapy on quality of life in a randomized trial. J Allergy Clin Immunol Pract, 9(12), 4493 - 4495.e1. DOI: 10.1016/j.jaip.2021.07.047
2018
Dunn Galvin A, McMahon S, Ponsonby A-L, Hsiao K-C, Tang MLK, PPOIT study team . (2018). The longitudinal impact of probiotic and peanut oral immunotherapy on health-related quality of life. Allergy, 73(3), 560 - 568. DOI: 10.1111/all.13330
2017
Hsiao K-C, Ponsonby A-L, Axelrad C, Pitkin S, Tang MLK, PPOIT Study Team . (2017). Long-term clinical and immunological effects of probiotic and peanut oral immunotherapy after treatment cessation: 4-year follow-up of a randomised, double-blind, placebo-controlled trial. Lancet Child Adolesc Health, 1(2), 97 - 105. DOI: 10.1016/S2352-4642(17)30041-X
Hsiao K-C, Ponsonby A-L, Axelrad C, Pitkin S, Tang MLK. (2017). Long Term Effects of a Probiotic and Peanut Oral Immunotherapy (PPOIT) Treatment on Peanut Allergic Children Journal of Allergy and Clinical Immunology, 139(2), ab136. DOI: 10.1016/j.jaci.2016.12.446
2015
Tang MLK, Ponsonby A-L, Orsini F, Tey D, Robinson M, Su EL, Licciardi P, Burks W, 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
2022
Loke P, Hsiao K-C, Lozinsky AC, Ashley SE, Lloyd M, Pitkin S, Axelrad CJ, Jayawardana KS, Tey D, Su EL, Robinson M, Leung ASY, Dunn Galvin A, Tang MLK. (2022). Probiotic peanut oral immunotherapy is associated with long-term persistence of 8-week sustained unresponsiveness and long-lasting quality-of-life improvement. Clin Exp Allergy, 52(6), 806 - 811. DOI: 10.1111/cea.14137
2022
Loke P, Orsini F, Lozinsky AC, Gold M, O'Sullivan MD, Quinn P, Lloyd M, Ashley SE, Pitkin S, Axelrad C, Metcalfe JR, Su EL, Tey D, Robinson MN, Allen KJ, Prescott SL, Galvin AD, Tang MLK, PPOIT-003 study group . (2022). Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial. Lancet Child Adolesc Health, 6(3), 171 - 184. DOI: 10.1016/S2352-4642(22)00006-2
2020
Chebar Lozinsky A, Loke P, Orsini F, O'Sullivan M, L Prescott S, Gold MS, Quinn P, DunnGalvin A, Lk Tang M, PPOIT study team . (2020). Study protocol of a 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 (the PPOIT-003 study). BMJ Open, 10(9), e035871. DOI: 10.1136/bmjopen-2019-035871
| Study Contacts | |
|---|---|
| Principal investigator/s |
Mimi Tang Paxton Loke |
| Project manager |
Julie Burns |
| Study Contact |
Email: peanut.study@mcri.edu.au |