Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance

NCT ID: NCT07192510

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-04-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

Pancake Oral Immunotherapy

Group Type: EXPERIMENTAL

Pancake oral immunotherapy

Intervention Type: OTHER

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

Control

Standard of care - strict egg avoidance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

OIT

Eligibility Criteria

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

• 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).
• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chong Kok Wee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Countries

Singapore

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PAEDSACP-TCL/2021/RES/002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIRB Ref: 2020/3072

Identifier Type: -

Identifier Source: org_study_id