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.




Trial phase Screening
(pre-trial)
Randomisation and RUSH day Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
Week 78+ DBPCFC
(minimum of 6 months maintenance)
Post treatment 1 clinic visit
(2 – 6 weeks after T1 DBPCFC )
Post treatment 2 clinic visit
(3 months after T1 DBPCFC)
Post treatment 3 phone interview
(6 months after T1 DBPCFC)
Post treatment 4 clinic visit
(12 months after T1 DBPCFC)
Post treatment 5 clinic visit
(3-4 years after T1 DBPCFC)
Follow up phone/email questionnaires
(every 6 months)
Final email/phone follow up
(3 years after T5)
Time point RUSH / T0 T1 T2 T3 T4 T5
No. 62
(96 screened)
PPOIT: 31
Placebo: 31
PPOIT: 29
Placebo: 28
PPOIT: 28
Placebo: 28
PPOIT: 28
Placebo: 28
PPOIT: 24
Placebo: 24
Month of study (minimum) 0 0 1-8 9-18 18 > 18.5 > 21 > 24 > 30 > 54-66 > 60-96 > 90-102
Allergies Allergies
Anthropometrics Anthropometrics
Birth
Demographics
General health
Medications and supplements Medications and supplements Medications and supplements Medications and supplements
Nutrition Nutrition Nutrition
Resilience and wellbeing Resilience and wellbeing Resilience and wellbeing
Respiratory health Respiratory health Respiratory health Respiratory health
Trial specific information Trial specific information
Bioanalyses and omics
Biosamples
Trial phase Sc
Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase (visit every 4 weeks) T2
(final day of study treatment)
T3
(8 weeks after end of study treatment)
T4
(1 year after end of study treatment)
T5
(3 years after end of study treatment)
Month of study 0 0 1-4 5-18 18 20 30 54
Allergies
Anthropometrics
Birth
Demographics
General health
Medications and supplements Medications and supplements
Nutrition Nutrition
Resilience and wellbeing Resilience and wellbeing
Respiratory health
Trial specific information
Bioanalyses and omics Bioanalyses and omics
Biosamples Biosamples
Trial phase Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase (visit every 12 weeks) T1
(1 day after final day of treatment)
T2
(12 weeks after final day of treatment)
Telephone Contact
(26 weeks after final day of treatment)
T3
(1 year after final day of treatment)
Month of study  up to -3 0 1-4 5-18 18 21 24 30
Week of study  up to -12 0 1-16 17-78 78 90 104 130
Allergies
Anthropometrics Anthropometrics
Birth
Demographics
General health
Medications and supplements
Nutrition
Resilience and wellbeing Resilience and wellbeing Resilience and wellbeing
Respiratory health
Trial specific information
Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics
Biosamples Biosamples Biosamples

 

Study 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 Ms Christine Axelrad
Primary Institution 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 for study (published study protocol) 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 to others outside study team? No, not at this time
Study focus (e.g. social development) 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 RCH Department of Allergy and Immunology outpatient clinics and through print media.
Study type (e.g. randomised control trial, cohort, case-control) Double-blind, placebo-controlled randomised trial
Year commenced 2008
Ongoing recruitment? No
Commencement sample (N) 62 (31 PPOIT, 31 placebo)
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? No
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? No
Biosamples (e.g. buccal, blood, hair)? Blood, faeces, saliva, posterior palatal swab, rectal swab (or faecal sample)
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)? This project only (Specific consent)
Year Age (mean, range) Eligible sample (not deceased, not withdrawn)
2008 – 2011 (Randomisation/RUSH day) PPOIT: 6.1 (SD 2.4)
Placebo: 5.8 (SD 2.6)
PPOIT: 31
Placebo: 31
2008 – 2011 (Build-up) Baseline + 1 – 8 months
2009 – 2013 (Maintenance) Baseline + 9 – 18 months
2010 – 2013 (Week 78+ T1 DBPCFC) Baseline + ≥ 18 months PPOIT: 29
Placebo: 28
2010 – 2013 (Post treatment 1) Baseline + ≥ 18.5 months PPOIT: 28
Placebo: 28
2010 – 2013 (Post treatment 2) Baseline + ≥ 21 months PPOIT: 28
Placebo: 28
2010 – 2013 (Post treatment 3) Baseline + ≥ 24 months
2011 – 2014 (Post treatment 4) Baseline + ≥ 30 months
2013 – 2016 (Post treatment 5) Baseline + 54 – 66 months PPOIT: 24
Placebo: 24
2013 – 2019 (6 monthly follow ups) Baseline + 60 – 96 months Ongoing
2016 – 2019 (Final follow up) Baseline + 90 – 102 months Ongoing
Study Summary
Study name Open pilot study of Probiotic and Peanut Oral Immunotherapy (PPOIT) with shortened buildup phase
Study abbreviation PPOIT-2/PPOIT-II
Current principal investigator/s Prof Mimi Tang
Current project manager Ms Christine Axelrad
Primary Institution Royal Children’s Hospital, Murdoch Childrens Research Institute
Major funding sources Murdoch Childrens Research Institute
Study website https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369539&isReview=true
Are data available to others outside study team? No, not at this time
Study focus (e.g. social development) 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 from the RCH Department of Allergy and Immunology outpatient clinics and through print media.
Study type (e.g. randomised control trial, cohort, case-control) Open pilot trial/intervention
Year commenced 2015
Ongoing recruitment? No
Commencement sample (N) 20
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? No
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? No
Biosamples (e.g. buccal, blood, hair)? Blood, faeces
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)? This project only (Specific consent)
Year Age (mean, range) Eligible sample (not deceased, not withdrawn)
2015 – 2016 (Screening) 20
2015 – 2016 (RUSH) Ongoing
2015 – 2016 (Build-up) Baseline + 1 – 4 months Ongoing
~ 2016 – 2017 (Maintenance) Baseline + 5 – 18 months Planned
~ 2017 (T2 – final day of treatment) Baseline + 18 months Planned
~ 2017 – 2018 (T3 – 8 weeks after end of treatment) Baseline + 20 months Planned
~ 2018 (T4 – 1 year after end of treatment) Baseline + 30 months Planned
~ 2020 (T5 – 3 years after end of treatment) Baseline + 54 months Planned
Study 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 Prof Mimi Tang
Current project manager Ms Christine Axelrad
Primary Institution Royal Children’s Hospital, Murdoch Childrens 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 Childrens Research Institute
Study website https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370172&isReview=true
Are data available to others outside study team? No, not at this time
Study focus (e.g. social development) 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 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 Childrens Research Institute (RCH/MCRI)
2. The Women’s and Children’s Hospital Adelaide (WCH)
3. Perth Children’s Hospital (PCH) / Princess Margaret Hospital
Study type (e.g. randomised control trial, cohort, case-control) Double-blind, placebo-controlled randomised trial
Year commenced July 2016
Ongoing recruitment? Yes
Target sample (N) 200, 80 PPOIT, 80 OIT only, 40 placebo
Annual recruitment rate Target to complete recruitment in early 2017
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? No
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? Access to medical records
Biosamples (e.g. buccal, blood, hair)? Blood, faeces
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)? This project only (Specific consent)
Year Age (mean, range) Eligible sample (not deceased, not withdrawn)
2016 – 2017 (Screening) Ongoing
2016 – 2017 (RUSH) Ongoing
2016 – 2017 (Build-up) Baseline + 1 – 4 months Ongoing
~ 2016 – 2018 (Maintenance) Baseline + 5 – 18 months Planned
~ 2018 (T1 – final day of treatment) Baseline + 18 months Planned
~ 2018 (T2 – 12 weeks after final day of treatment) Baseline + 21 months Planned
~ 2018 – 2019 (6 months after final day of treatment) Baseline + 24 months Planned
~ 2019 (T3 – 1 year after final day of treatment) Baseline + 30 months Planned

Principal Investigator

Prof Mimi Tang

Project Manager

Ms Christine Axelrad
Phone: +613 9345 6974
Email: Christine.Axelrad@rch.org.au

Postal Address

Allergy and Immune Disorders
Murdoch Childrens Research Institute
Flemington Rd
Parkville, Victoria 3052
Australia