Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance (NCT07192510) | Clinical Trial Compass
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 range
2 Years – 15 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein