Egg AllergyPOETNCT07192510
Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance
A study testing Pancake oral immunotherapy in people with Egg Allergy, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Oral immunotherapy (OIT) using raw/ cooked egg has good desensitisation outcomes but is associated with frequent and sometimes severe adverse events (anaphylaxis is not uncommon). OIT using baked egg is less effective at inducing desensitisation but has a better safety profile. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Egg Allergy
- What is being tested?
- Pancake oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2021to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Allergic to 4.443g egg protein or less, at baseline egg open food challenge OR Convincing clinical reaction to egg within past 6 months (or failed a clinical egg food challenge in last 6 months) AND evidence of current sensitization (positive SPT or egg-specific IgE performed within the last 3 months)
Who cannot join
- Subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
- Required previous admission to an intensive care unit for management of an allergic reaction.
- Children with a past history of egg allergy currently consuming egg-containing products other than extensively-heated egg in baked foods (e.g. biscuits, cakes).
- Developed severe anaphylaxis to egg or egg-containing products requiring more than 2 adrenaline auto-injectors or intravenous adrenaline infusion.
- Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON guidelines).
- Moderate-severe eczema despite appropriate use of emollients (eczema is not otherwise an exclusion criteria).
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- Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- History of symptoms of eosinophilic oesophagitis, irrespective of cause.
- Undergoing specific immunotherapy to another allergen and within the first year of treatment.
- Receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACE inhibitor.
- Pregnancy.
- Unwilling or unable to fulfil study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance (POET)
Oral immunotherapy (OIT) using raw/ cooked egg has good desensitisation outcomes but is associated with frequent and sometimes severe adverse events (anaphylaxis is not uncommon). OIT using baked egg is less effective at inducing desensitisation but has a better safety profile. The compliance to daily consumption of baked egg products (muffins/ biscuits) after a negative baked egg challenge in egg allergic patients has also been reported to be poor, secondary to taste fatigue in children and need for frequent baking. A study using baked egg OIT had 38% withdrawal due to difficulties in ingesting the baked egg product daily. Pancakes, traditionally described as a flat cake prepared from a starch-based batter containing egg and milk and cooked on a hot surface for 5-7 minutes, is likely to be less allergenic than cooked egg because of the wheat matrix but more allergenic than baked egg. To date, there are no published studies investigating the use of pancakes in egg OIT. The investigators hypothesize that pancakes are more effective than baked eggs in inducing desensitisation and sustained unresponsiveness while reducing the risk of adverse events associated with egg OIT.
- Conditions
- Egg Allergy
- Being tested
- Pancake oral immunotherapy
- Keywords
- oral immunotherapy
- Medical subject headings
- Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancake oral immunotherapyOther
Also called OIT
The baked egg tolerant group underwent a 4-dose initial escalation (at intervals of 20-30 minutes) with pancakes in hospital (37.5 mg, 75 mg, 150 mg, 300 mg egg protein) to determine the home starting dose of pancake. The dose tolerated was one which resulted in no more than mild transient (not lasting more than 20 minutes) symptoms (e.g. itchy mouth) - transient Grade 1 symptoms. The home starting dose (taken daily at home) was one step below the tolerated dose, to minimise risk of allergic reactions at home, particularly as the presence of co-factors might decrease reaction threshold. Those reacting at 37.5 mg or 75 mg would not begin OIT with pancakes but instead began with cookies. Updosing visits were performed in the hospital at approximately 4 weekly intervals. Participants were kept at the pancake daily maintenance dose (2500 mg) for a minimum of 16 weeks, or total OIT duration of 18 months, whichever earlier
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Pancake Oral Immunotherapy Receives: Other: Pancake oral immunotherapy |
| Control | No intervention | Standard of care - strict egg avoidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein
Measured: 12-18 months
Secondary outcomes (5)
Proportion of participants achieving sustained unresponsiveness - tolerating a cumulative dose of 4443 mg cooked egg protein after 6-8 weeks of egg abstinence
Measured: 12-18 months
Number of treatment-related adverse reactions as assessed by CoFAR Grading
Consortium for Food Allergy Research (CoFAR) grading system: Grade 1-2 (Mild-moderate reactions), Grade 3-5 (Anaphylaxis)
Measured: 12-18 months
Change in skin prick test wheal size to egg white
Measured: 12-18 months
Change in serum IgE levels to egg white, ovomucoid, ovalbumin
Measured: 12-18 months
Change in Food-Allergy Quality of Life Questionnaire (FAQL-Q) scores
Total mean score range 0-6. The higher the mean score the poorer the quality of life.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Apr 2021
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg AllergyStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chong Kok Wee, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192510
- Sponsor's protocol ID
- CIRB Ref: 2020/3072
- Other IDs
- PAEDSACP-TCL/2021/RES/002
- Acronym
- POET
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance (POET)
- ClinicalTrials.gov ID
- NCT07192510
- Acronym / sponsor ID
- POET / CIRB Ref: 2020/3072
- Conditions
- Egg Allergy
- Keywords
- oral immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 25 Sep 2025 (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.
Oral immunotherapy (OIT) using raw/ cooked egg has good desensitisation outcomes but is associated with frequent and sometimes severe adverse events (anaphylaxis is not uncommon). OIT using baked egg is less effective at inducing desensitisation but has a better safety profile. The compliance to daily consumption of baked egg products (muffins/ biscuits) after a negative baked egg challenge in egg allergic patients has also been reported to be poor, secondary to taste fatigue in children and need for frequent baking. A study using baked egg OIT had 38% withdrawal due to difficulties in ingesting the baked egg product daily. Pancakes, traditionally described as a flat cake prepared from a starch-based batter containing egg and milk and cooked on a hot surface for 5-7 minutes, is likely to be less allergenic than cooked egg because of the wheat matrix but more allergenic than baked egg. To date, there are no published studies investigating the use of pancakes in egg OIT. The investigators hypothesize that pancakes are more effective than baked eggs in inducing desensitisation and sustained unresponsiveness while reducing the risk of adverse events associated with egg OIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Pancake oral immunotherapyPancake Oral Immunotherapy |
| Control | No intervention | –Standard of care - strict egg avoidance |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Allergic to 4.443g egg protein or less, at baseline egg open food challenge OR Convincing clinical reaction to egg within past 6 months (or failed a clinical egg food challenge in last 6 months) AND evidence of current sensitization (positive SPT or egg-specific IgE performed within the last 3 months)
Key exclusion criteria (12 listed)
- Subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
- Required previous admission to an intensive care unit for management of an allergic reaction.
- Children with a past history of egg allergy currently consuming egg-containing products other than extensively-heated egg in baked foods (e.g. biscuits, cakes).
- Developed severe anaphylaxis to egg or egg-containing products requiring more than 2 adrenaline auto-injectors or intravenous adrenaline infusion.
- Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON guidelines).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancake oral immunotherapyAlso: OITThe baked egg tolerant group underwent a 4-dose initial escalation (at intervals of 20-30 minutes) with pancakes in hospital (37.5 mg, 75 mg, 150 mg, 300 mg egg protein) to determine the home starting dose of pancake. The dose tolerated was one which resulted in no more than mild transient (not lasting more than 20 minutes) symptoms (e.g. itchy mouth) - transient Grade 1 symptoms. The home starting dose (taken daily at home) was one step below the tolerated dose, to minimise risk of allergic reactions at home, particularly as the presence of co-factors might decrease reaction threshold. Those reacting at 37.5 mg or 75 mg would not begin OIT with pancakes but instead began with cookies. Updosing visits were performed in the hospital at approximately 4 weekly intervals. Participants were kept at the pancake daily maintenance dose (2500 mg) for a minimum of 16 weeks, or total OIT duration of 18 months, whichever earlier | Other | Active |
Primary outcome
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein
Time frame: 12-18 months
5 secondary outcomes
Proportion of participants achieving sustained unresponsiveness - tolerating a cumulative dose of 4443 mg cooked egg protein after 6-8 weeks of egg abstinence
Time frame: 12-18 months
Number of treatment-related adverse reactions as assessed by CoFAR Grading
Time frame: 12-18 months
Change in skin prick test wheal size to egg white
Time frame: 12-18 months
Change in serum IgE levels to egg white, ovomucoid, ovalbumin
Time frame: 12-18 months
Change in Food-Allergy Quality of Life Questionnaire (FAQL-Q) scores
Time frame: 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancake oral immunotherapy in people with Egg Allergy, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 25 Sep 2025. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein (time frame: 12-18 months). 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 25 Sep 2025.