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

KK Women's and Children's Hospital

Status

Completed

Conditions

Egg Allergy

Treatments

Other: Pancake oral immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07192510

CIRB Ref: 2020/3072

PAEDSACP-TCL/2021/RES/002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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.