An observational study in Food Allergies, Peanut Allergies and Egg Allergy, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Murdoch Childrens Research Institute · Observational
The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to:
Participants will attend a single follow-up visit for:
The study population will be made up of participants from four clinical trials: PEAT, PrEMO, PPOIT-001 and PPOIT-002. They are being invited to participate in the LPEM observational study to evaluate the long-term outcomes of OIT.
Participants will have a blood sample taken at the visit to measure their peanut/egg/milk specific immunoglobulin E (sIgE) level. Plasma and peripheral blood mononuclear cells (PBMC) will also be stored for future analysis. A maximum of 50 milliliters (mL) of blood will be collected via venipuncture. If collection of blood via venipuncture is not possible, capillary blood via fingerprick technique will be collected instead (in which case only blood for the sIgE level will be collected, due to volume).
Participants will have a skin prick test completed at the visit to measure their allergy status. The skin prick test will include the following extracts:
376 studies on the registry are indexed under Food Hypersensitivity; 90 are open to participants now.
This study's planned enrollment of 147 is close to the median of 151 across 120 observational studies indexed under Food Hypersensitivity.
Browse Food Hypersensitivity studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Up to 147 participants will be recruited from the PEAT, PrEMO, PPOIT-001 and PPOIT-002 studies (Melbourne participants only), who received at least one dose of OIT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Changes in health-related quality of life (HRQL) scores from baseline to 5-15 years after stopping oral immunotherapy (OIT) in individuals who achieved remission and those who did not, as measured by Food Allergy Quality of Life Questionnaires (FAQLQ).
HRQL scores were collected via validated surveys (FAQLQ) during the parent studies (PEAT, PrEMO, PPOIT-001 and PPOIT-002), and will be used again in this study for comparison. Changes in HRQL scores from the parent study (baseline) to 5-15 years after stopping OIT will be compared between the clinical outcome groups (Allergic or Sustained Unresponsiveness (SU)/Remission), as determined by the clinical outcome achieved at the end of treatment in the parent study. HRQL scores (reported as mean and standard deviation) will compare changes between the clinical outcome groups using generalised linear modules, adjusted for continuous variables as well as baseline HRQL scores. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Changes in HRQL scores from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by FAQLQ.
HRQL scores were collected via validated surveys (FAQLQ) during the parent studies (PEAT, PrEMO, PPOIT-001 and PPOIT-002), and will be used again in this study for comparison. Changes in HRQL scores from the parent study (baseline) to 5-15 years after stopping OIT will be compared between the treatment groups (OIT or placebo), as determined by the treatment group allocated in the parent study. HRQL scores (reported as mean and standard deviation) will compare changes between the treatment groups using linear regression adjusted for baseline HRQL scores. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire.
Participants will complete a REDCap Allergen Specific Questionnaire indicating the number (0, 1, 2, 3, 4, 5, more than 5) of allergic reactions they experienced in the preceding 12 months to the allergen they received OIT treatment for in the parent study (peanut, egg or milk). In this REDCap Allergen Specific Questionnaire, participants will also indicate the number of times an Adrenaline Autoinjector was required for the management of the allergic reaction/s (0, 1, 2, 3, 4, 5, more than 5) in the preceding 12 months. Comparisons (reported as mean and standard deviation) will be made between the clinical outcome groups (Allergic or Sustained Unresponsiveness (SU)/Remission), as determined by the clinical outcome achieved at the end of treatment in the parent study. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
The incidence and severity of allergic reactions (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by REDCap Allergen Specific Questionnaire.
Participants will complete a REDCap Allergen Specific Questionnaire indicating the number (0, 1, 2, 3, 4, 5, more than 5) of allergic reactions they experienced in the preceding 12 months to the allergen they received OIT treatment for in the parent study (peanut, egg or milk). In this REDCap Allergen Specific Questionnaire, participants will also indicate the number of times an Adrenaline Autoinjector was required for the management of the allergic reaction/s (0, 1, 2, 3, 4, 5, more than 5) in the preceding 12 months. Comparisons (reported as mean and standard deviation) will be made between the treatment groups (OIT or placebo), as determined by the treatment group allocated in the parent study. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Patterns of food ingestion (in the preceding 12 months) at 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by REDCap Allergen Specific Questionnaire.
Participants will complete a REDCap Allergen Specific Questionnaire indicating ingestion in the preceding 12 months (yes/no) of the allergen they received OIT treatment for in the parent study (peanut, egg or milk). Comparisons (reported as absolute and relative frequencies) will be made between the clinical outcome groups (Allergic or Sustained Unresponsiveness (SU)/Remission), as determined by the clinical outcome achieved at the end of treatment in the parent study. Categorical outcomes such as allergen intake (yes/no) will be summarised as the number and proportion of subjects by clinical outcome group.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who achieved remission and those who did not, as measured by allergen specific immunoglobulin E (sIgE) blood levels.
Allergen specific immunoglobulin E (sIgE) blood levels were collected during the parent studies (PEAT, PrEMO, PPOIT-001 and PPOIT-002) and will be collected again in this study for comparison. Changes (reported as mean and standard deviation) in sIgE blood levels from the parent study (baseline) to 5-15 years after stopping OIT will be compared between the clinical outcome groups (Allergic or Sustained Unresponsiveness (SU)/Remission), as determined by the clinical outcome achieved at the end of treatment in the parent study. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Changes in immunological markers from baseline to 5-15 years after stopping OIT in individuals who received OIT and those who received OIT placebo, as measured by allergen specific immunoglobulin E (sIgE) blood levels.
Allergen specific immunoglobulin E (sIgE) blood levels were collected during the parent studies (PEAT, PrEMO, PPOIT-001 and PPOIT-002) and will be collected again in this study for comparison. Changes (reported as mean and standard deviation) in sIgE blood levels from the parent study (baseline) to 5-15 years after stopping OIT will be compared between the treatment groups (OIT or placebo), as determined by the treatment group allocated in the parent study. If continuous outcomes do not follow normal distribution they will be summarised as median and interquartile ranges (IQR), and comparison between the groups will be performed using the Wilcoxon rank-sum (Mann-Whitney) test.
Time frame: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Plan to share: Yes — Data will be collected and stored in such a way that they can be used in future research projects. After 24 months following analysis and article publication, data may be made available for long-term use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access (including any conditions relating to MCRI's intellectual property).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 24 months following analysis and article publication
Access criteria: Data will be collected and stored in such a way that they can be used in future research projects. After 24 months following analysis and article publication, data may be made available for long-term use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access (including any conditions relating to MCRI's intellectual property).
Data sharing details ↗ · www.mcri.edu.au
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 42 non-industry observational studies under Food Hypersensitivity, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 250. This study's planned 12 months is below that.
Counting every sponsor, half of 43 studies reached it within 42 months; a quarter within 19 and three quarters within 250.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Murdoch Childrens Research Institute