CompletedNot Applicable

Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance

Singapore23 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range2 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 12-18 months

Trial details

NCT IDNCT07192510

SponsorKK Women's and Children's Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-04-16