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CompletedNCT07192510POETUpdated Sep 25, 2025

Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance

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

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
2 Years to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Egg Allergy

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Keywords

  • oral immunotherapy
03

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Active

    Pancake Oral Immunotherapy

    Other: Pancake oral immunotherapy

  • No intervention
    Control

    Standard of care - strict egg avoidance

Interventions

  • OtherPancake oral immunotherapy

    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

05

What researchers measure

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

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

    Time frame: 12-18 months

  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

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

    Time frame: 12-18 months

06

Study locations

1 site
  • KK Women's and Children's Hospital
    Singapore, Singapore
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07192510
Lead sponsor
KK Women's and Children's Hospital
Responsible party
Chong Kok Wee (Principal Investigator, KK Women's and Children's Hospital) — Principal investigator
First posted
Sep 25, 2025
Start date
Apr 1, 2021
Primary completion
Apr 16, 2025
Completion
Apr 16, 2025
Last update
Sep 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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