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Completed

NCT Number: NCT07192510

Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance

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.

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Key information

Conditions

Egg Allergy Egg Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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).
  • 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.

Treatment and study plan

Pancake oral immunotherapy

Other

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

Other names: OIT

Primary outcomes

  1. Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein

    Time frame: 12-18 months

Secondary outcomes

  1. 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

  2. Number of treatment-related adverse reactions as assessed by CoFAR Grading

    Time frame: 12-18 months

    Consortium for Food Allergy Research (CoFAR) grading system: Grade 1-2 (Mild-moderate reactions), Grade 3-5 (Anaphylaxis)

  3. Change in skin prick test wheal size to egg white

    Time frame: 12-18 months

  4. Change in serum IgE levels to egg white, ovomucoid, ovalbumin

    Time frame: 12-18 months

  5. Change in Food-Allergy Quality of Life Questionnaire (FAQL-Q) scores

    Time frame: 12-18 months

    Total mean score range 0-6. The higher the mean score the poorer the quality of life.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance (POET)

Acronym: POET

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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