A Long Term, Observational Follow-Up Study of Children and Young People Who Underwent an 18-Month Course of Oral Immunotherapy Treatment for Peanut, Egg or Milk Allergy (5-15 Years Post-Treatment) (LPEM)

Long Term Outcomes Associated With Attainment of Remission Following Oral Immunotherapy to Peanut, Egg and Cow's Milk (LPEM Study)

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:

• Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not.

Participants will attend a single follow-up visit for:

• A blood test
• Skin prick test (SPT)
• Allergy questionnaires

Study Overview

• Status: Recruiting
• Conditions: Egg Allergy; Food Allergies; Milk Allergy; Peanut Allergies

Detailed Description

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.

• PEAT: Egg OIT. These participants are from the PEAT parent study (double-blind placebo-controlled randomized trial of probiotic and egg OIT).
• PrEMO: Egg or Milk OIT. These participants are from the PrEMO parent study (open label study of probiotic and egg and cow's milk OIT).
• PPOIT-001: Peanut OIT. These participants are from the PPOIT-001 parent study (double-blind placebo-controlled randomized trial of probiotic and peanut OIT).
• PPOIT-002: Peanut OIT. These participants are from the PPOIT-002 parent study (open label study of probiotic and peanut 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:

• Positive control (histamine)
• Negative control (saline)
• House Dust Mite
• Rye Grass
• Peanut, Egg or Milk (depending on the participant's OIT treatment received in the parent study)

• Study Type: Observational
• Enrollment (Estimated): 147

Contacts and Locations

• Study Contact: Name: Adriana Chebar Lozinsky Rolnik; Phone Number: 61399366435; Email: lpem.study@mcri.edu.au
• Study Contact Backup: Name: Amanda Burgess; Phone Number: +61383416200; Email: lpem.study@mcri.edu.au

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Recruiting
      • Murdoch Children's Research Institute
      • Contact: Adriana Chebar Lozinsky Rolnik; Phone Number: 61399366435; Email: lpem.study@mcri.edu.au
      • Principal Investigator: Adriana Chebar Lozinsky Rolnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Previous participant of PEAT, PrEMO, PPOIT-001 or PPOIT-002 parent study
• Received at least one dose of OIT treatment in the parent study
• Written informed consent from participant and/or parent/guardian (if below 18 years of age)

Exclusion Criteria:

-Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	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.	A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Investigators: Principal Investigator: Adriana Chebar Lozinsky Rolnik, Murdoch Childrens Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity
• Other Study ID Numbers: 121398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: 24 months following analysis and article publication
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No