Food AllergiesLPEMNCT07359183
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)
An observational study of Food Allergies and Peanut Allergies, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergies, Peanut Allergies, Egg Allergy
- How many people
- 147 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- -Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Murdoch Children's Research Institute
Parkville, Victoria, 3052
Adriana Chebar Lozinsky Rolnik, 61399366435, lpem.study@mcri.edu.au
Adriana Chebar Lozinsky Rolnik
About this study
Official title: 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
Read the 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)
- Conditions
- Food Allergies, Peanut Allergies, Egg Allergy, Milk Allergy
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Egg Hypersensitivity, Milk Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: A single study visit (approximately 2 hours) will be conducted at 5-15 years after the participant completed OIT in their parent study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start13 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergiesStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Chebar Lozinsky Rolnik, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359183
- Sponsor's protocol ID
- 121398
- Acronym
- LPEM
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes Associated With Attainment of Remission Following Oral Immunotherapy to Peanut, Egg and Cow's Milk (LPEM Study)
- ClinicalTrials.gov ID
- NCT07359183
- Acronym / sponsor ID
- LPEM / 121398
- Conditions
- Food Allergies, Peanut Allergies, Egg Allergy, Milk Allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adriana Chebar Lozinsky Rolnik principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergies and Peanut Allergies, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana Chebar Lozinsky Rolnik (61399366435, lpem.study@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.