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Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance

NCT07192510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-25

No results posted yet for this 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.

Conditions

  • Egg Allergy

Interventions

OTHER

Pancake 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

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-04-16
Completion
2025-04-16

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07192510 on ClinicalTrials.gov