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)

NCT07359183 | Recruiting

• 1 other identifier: 121398
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergies; Peanut Allergies; Egg Allergy; Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood - plasma and peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Egg Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Adriana Chebar Lozinsky Rolnik

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Chebar Lozinsky Rolnik

CONTACT

61399366435; lpem.study@mcri.edu.au

Amanda Burgess

CONTACT

+61383416200; lpem.study@mcri.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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).

Locations

AU (1)