An interventional study of Pancake oral immunotherapy in Egg Allergy, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
Pancake Oral Immunotherapy
Other: Pancake oral immunotherapy
Standard of care - strict egg avoidance
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
Also known as: OIT
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein
Time frame: 12-18 months
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
Consortium for Food Allergy Research (CoFAR) grading system: Grade 1-2 (Mild-moderate reactions), Grade 3-5 (Anaphylaxis)
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
Total mean score range 0-6. The higher the mean score the poorer the quality of life.
Time frame: 12-18 months
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KK Women's and Children's Hospital