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Trial registered on ANZCTR


Registration number
ACTRN12619000898156
Ethics application status
Approved
Date submitted
5/06/2019
Date registered
26/06/2019
Date last updated
26/06/2019
Date data sharing statement initially provided
26/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Follow-on study of a multicentre randomised, controlled trial (PPOIT-003) evaluating the long-term safety and efficacy of Probiotic and Peanut Oral Immunotherapy (PPOIT) compared with Oral Immunotherapy (OIT) alone and with placebo in peanut allergic individuals
Scientific title
Follow-on study of a multicentre randomised, controlled trial (PPOIT-003) evaluating the long-term safety and efficacy of Probiotic and Peanut Oral Immunotherapy (PPOIT) compared with Oral Immunotherapy (OIT) alone and with placebo in peanut allergic individuals
Secondary ID [1] 298398 0
NIL
Universal Trial Number (UTN)
Trial acronym
PPOIT-003LT
Linked study record
This record is a follow-up study of ACTRN12616000322437 (A multicentre, randomized, 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)

Health condition
Health condition(s) or problem(s) studied:
Peanut Allergy 313093 0
Food Allergy 313094 0
Condition category
Condition code
Inflammatory and Immune System 311578 311578 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a multicentre follow-on study of the PPOIT-003 study (ACTRN12616000322437). There is no treatment intervention in this study.

Although it is a follow -on study, PPOIT-003LT has been approved under a separate ethics submission.

All participants who complete the PPOIT-003 will be eligible for enrolment into this follow-on study.

Subjects and study staff will remain blinded to their PPOIT-003 treatment allocation and will continue with peanut avoidance or ingestion according to the instructions they received at the end of treatment in PPOIT-003 (based upon their treatment outcome at end of treatment in PPOIT-003).

All subjects will be monitored for a further 14 months (from 12 months post treatment to 26 months post treatment).

F0 (First visit):
- The following assessments will be conducted: skin prick test, medical history review, blood and stool collection, Food Allergy Quality of Life questionnaire.

F1 visit (12 months after F0 or 2 years after final day of treatment):
- All study participants will complete a Double-Blind Placebo-Controlled Food Challenge (DBPCFC) over two days.
- The following assessments will also be conducted: skin prick test, medical history review, blood and stool collection, Food Allergy Quality of Life questionnaire.

F2 visit - 8 weeks after F1:
- Participants who pass the F1 DBPCFC will complete a second DBPCFC.
- Participants who fail the F1 DBPCFC will not have a DBPCFC.
- The following assessments will be conducted for all participants: skin prick test, medical history review, blood and stool collection, Food Allergy Quality of Life questionnaire.
Intervention code [1] 314643 0
Not applicable
Comparator / control treatment
Active control (peanut avoidance) with no treatment given,
Control group
Active

Outcomes
Primary outcome [1] 320281 0
Percentage of subjects who demonstrate Sustained Unresponsiveness (SU) at 26 months post treatment in Probiotic and Peanut Oral ImmunoTherapy (PPOIT), Oral ImmunoTherapy (OIT) and placebo groups, assessed using the DBPCFC.

This a composite outcome.
Timepoint [1] 320281 0
F2 visit - 14 months after F0 or 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)

Secondary outcome [1] 371127 0
Percentage of subjects who demonstrate Desensitisation (DS) at at 26 months post treatment in PPOIT, OIT and placebo groups, assessed using the DBPCFC.

This a composite secondary outcome.
Timepoint [1] 371127 0
F2 visit - 14 months after F0 or 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [2] 371128 0
Percentage of subjects who demonstrate SU at 26 months post treatment (assessed using the DBPCFC) amongst the PPOIT-treated and OIT-treated subjects who attained SU at the end of treatment in PPOIT-003.

This a composite secondary outcome.


Timepoint [2] 371128 0
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [3] 371129 0
Percentage of subjects with DS at the end of treatment and DS at 26 months post treatment, assessed using the DBPCFC (by passing the F1 DBPCFC).
Timepoint [3] 371129 0
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [4] 371130 0
To evaluate longitudinal changes in peanut and peanut component sIgE and sIgG4 levels and peanut skin prick test (SPT) from PPOIT-003 study baseline at 24 and 26 months post-treatment in PPOIT, OIT and placebo groups.

This a composite secondary outcome.

sIgE levels and sIgG4 levels will be assessed using plasma samples and measured by ImmunoCAP (Phadia).
Timepoint [4] 371130 0
F1 visit - 24 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [5] 371132 0
Quality of life score and change in quality of life score from baseline (study entry to PPOIT-003) at 26 months post-treatment in PPOIT, OIT and placebo groups.

This a composite secondary outcome.

The validated Food Allergy Quality of Life-Parent Form (FAQLQ-PF) completed by the parents on behalf of the children will be used.
Timepoint [5] 371132 0
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [6] 371133 0
Proportion of subjects who are ingesting peanut in their diet during the follow-on study phase. This is assessed using the follow-up diary (recording peanut ingestion or reactions) provided to the participants during the follow-up study.
Timepoint [6] 371133 0
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)
Secondary outcome [7] 371703 0
Proportion of subjects who are having reactions to peanut ingestion (intentional or accidental) during the follow-on study phase. This is assessed using the follow-up diary (recording peanut ingestion or reactions) provided to the participants during the follow-up study.
Timepoint [7] 371703 0
F2 visit - 26 months after final day of treatment in PPOIT-003 (ACTRN12616000322437)

Eligibility
Key inclusion criteria
Completion of the PPOIT-003 T2 visit according to PPOIT-003 protocol.
Enrolment into the PPOIT-003 study.
Minimum age
3 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Did not complete the PPOIT-003 T2 visit
Currently taking probiotic supplements (does not include formula, yoghurts and fermented foods).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
PPOIT-003LT will be analysed according to the intention-to-treat (ITT) principle. Subjects will be compared according to the group to which they were originally randomly allocated, regardless of subjects' compliance, crossover to other treatments or withdrawal from the follow-on study.

Additional analyses on safety will be conducted comparing subjects by their outcome at T2 of PPOIT-003 – SU vs desensitisation vs allergic.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC
Recruitment hospital [1] 13894 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 13895 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 13896 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 26667 0
3052 - Parkville
Recruitment postcode(s) [2] 26668 0
6009 - Nedlands
Recruitment postcode(s) [3] 26669 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 302939 0
Commercial sector/Industry
Name [1] 302939 0
Prota Therapeutics
Address [1] 302939 0
Level 14/90 Collins St, Melbourne VIC 3000
Country [1] 302939 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital, 50 Flemington Road, Parkville 3052
Country
Australia
Secondary sponsor category [1] 303062 0
None
Name [1] 303062 0
Address [1] 303062 0
Country [1] 303062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303501 0
Royal Children’s Hospital (RCH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 303501 0
Royal Children's hospital, 50 Flemington Road Parkville, 3052
Ethics committee country [1] 303501 0
Australia
Date submitted for ethics approval [1] 303501 0
11/03/2019
Approval date [1] 303501 0
18/04/2019
Ethics approval number [1] 303501 0
2019.026

Summary
Brief summary
The aims of the PPOIT-003 randomised trial was to evaluate if Probiotic and Peanut Oral Immunotherapy (PPOIT) is more effective than placebo in inducing sustained unresponsiveness (SU) in children with peanut allergy, and more effective than peanut OIT alone, in inducing SU in children with peanut allergy.

This is a follow-on study for all participants who complete the PPOIT-003 randomised trial in order to evaluate whether the beneficial effects of PPOIT (at inducing sustained unresponsiveness or desensitization) are maintained out to 24 months post treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93882 0
Dr Paxton Loke
Address 93882 0
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Country 93882 0
Australia
Phone 93882 0
+61 422764232
Fax 93882 0
+61 3 9345 4848
Email 93882 0
paxton.loke@mcri.edu.au
Contact person for public queries
Name 93883 0
Ms Molly O'Sullivan
Address 93883 0
Allergy Immunology Group
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Country 93883 0
Australia
Phone 93883 0
+61 3 8341 6229
Fax 93883 0
+61 3 9345 4848
Email 93883 0
molly.osullivan@mcri.edu.au
Contact person for scientific queries
Name 93884 0
Ms Molly O'Sullivan
Address 93884 0
Allergy Immunology Group
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Country 93884 0
Australia
Phone 93884 0
+61 3 8341 6229
Fax 93884 0
+61 3 9345 4848
Email 93884 0
molly.osullivan@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study protocol, documentation, data and all other information generated will be held in strict confidence. No information concerning the study or the data will be released to any unauthorised third party, without prior written approval of the sponsoring institution.

Authorised representatives of the sponsoring institution may inspect all documents and records required to be maintained by the Site Investigator, including but not limited to, medical records (office, clinic or hospital) and pharmacy records for the participants in this study.

All laboratory specimens, evaluation forms, reports and other records that leave the site will be identified only by the Participant Identification Number (SID) to maintain participant confidentiality. Clinical information will not be released without written permission of the participant, except as necessary for monitoring by HREC or regulatory agencies.
What supporting documents are/will be available?
No other documents available
Summary results
No Results