Study Results
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Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2016-06-01
2019-12-01
Brief Summary
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Until now, the usual way to manage a food allergy has been to completely avoid the food. But this can be hard, limiting kids diets and puts them at risk of accidental exposure, and may even cause nutritional problems.
Oral immunotherapy (OIT) has become and alternative treatment. It consists in giving very small amounts of the food allergen regularly to help the body get used to it. Some studies show this helps children build tolerance faster than just avoiding the food. But OIT also comes with risks, including allergic reactions during the treatment, some of which can be serious.
Some research is focusing on a gentler and safer option: giving children baked milk or baked egg. When milk or egg is baked (for example, in muffins or cookies), the high heat changes the proteins, making them less likely to cause allergic reactions. The heat breaks the parts of the protein that the immune system usually reacts to, and mixing them with wheat flour makes them even less reactive.
Interestingly, this doesn't work for every food, peanuts, for example, can actually become more allergenic when heated. But in the case of milk and egg, baking seems to be very helpful.
Giving baked milk or egg to allergic children has shown some immune system changes similar to OIT, but in a safer and more natural way. This can make life a lot easier, not just for the kids, but also for their families since it broadens their diet, improves their nutrition, and reduces stress in social situations.
Studies suggest that introducing baked milk and egg early on could also help kids become fully tolerant sooner.
At Sant Joan de Déu Hospital in Barcelona, doctors have been using OIT for milk and egg allergies since 2006 in children over 5 years old. While the treatment has helped many, not all children become fully desensitized, and some still react to milk or egg occasionally. The success rate is around 70%, and it's often less effective in children with severe allergies, like those who have had anaphylaxis.
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Detailed Description
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Study Population Inclusion Criteria Age: 12 to 72 months (1 to 6 years). Milk Allergy Subgroup: Confirmed diagnosis based on at least one of the following: suggestive clinical history, positive skin prick test (SPT) ≥3 mm over negative control and/or specific IgE ≥0.35 kU/L to cow's milk or casein.
Egg Allergy Subgroup: Either: suggestive clinical history and sensitization (SPT or sIgE ≥0.35 kU/L to egg white or ovomucoid).
Exclusion Criteria Inability to obtain written informed consent. Any contraindication to epinephrine use (e.g., uncorrected congenital heart disease).
Ongoing consumption of baked milk or egg ≥3 times/week within the last 3 months.
Baseline Procedures and Immune Profiling (T0)
All participants will undergo:
Supervised Oral Food Challenge (OFC) with a standardized baked milk or egg product (e.g., muffin containing measured protein quantity), carried out under hospital supervision with immediate access to emergency care.
Blood Sampling for:
Quantitative allergen-specific IgE, IgG4, IgA to milk/egg and their major components (e.g., casein, ovomucoid).
Flow cytometry for T-cell phenotyping (CD4⁺CD25⁺FoxP3⁺ regulatory T cells). Cytokine profiling via ELISA or multiplex immunoassay: IL-4, IL-5, IL-10, IL-13, TGF-β.
Basophil Activation Test (BAT) using CD63/CD203c expression upon allergen stimulation.
Skin Prick Testing with commercial milk/egg extracts and baked food extracts, if available.
Randomization and Treatment Arms
Participants are stratified based on baked food OFC outcome:
A. OFC-Positive to Baked Product
Randomized 1:1 to:
Baked Group 1 (Low-dose exposure): Daily ingestion of baked product containing fixed dose (e.g., 0.0375 g milk protein or 0.11 g egg protein).
Control Group 1 (Strict avoidance): Elimination of all milk/egg and derivatives.
Non-tolerant to minimum baked dose: Excluded from active intervention; followed as observational cohort with repeated testing at 12 months.
B. OFC-Negative to Baked Product Progress to OFC with pasteurized milk or cooked egg. If tolerant → study exit.
If reactive, randomization into:
Baked Group 2 (High-dose exposure): Daily ingestion of baked food containing higher protein load (e.g., 0.55 g milk protein or 1.1 g egg protein).
Control Group 2 (Strict avoidance).
All OFCs use a standardized 6-step titration protocol with cumulative dosing and observation for ≥2 hours post-ingestion.
Dose Escalation and Monitoring After 6 months: Hospital-based supervised dose escalation (doubling daily intake) for Baked Groups 1 and 2.
Final Assessment (T1 - 12 months) Repeat OFC with unheated (raw) milk or cooked/raw egg. Repeat blood testing, SPT, and BAT.
Comparative analysis between baseline and T1 to determine:
Acquisition of tolerance (negative OFC). Immune modulation (e.g., shifts in IgE/IgG4 ratios, Treg expansion, cytokine profile normalization).
Predictive value of baseline biomarkers for outcome stratification.
This detailed protocol structure enables reproducibility, comparability, and the possibility of identifying immunological biomarkers that correlate with successful oral immunotolerance induction through gradual dietary exposure to baked allergens.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dietary intervention with cow's milk or egg baked cookies low dose
Baked Group 1: consume a daily fixed low dose of baked milk (0.0375g of milk protein) or baked egg (0.11 g of egg protein).
Dietary intervention using cookies containing milk or egg low dose.
Baked Group 1: consumed a daily fixed low dose of baked milk or egg (0.0375 g of milk protein or 0.11 g of egg protein) for 6 months, followed by an additional increase at that time (0.075 g or 0.22 g).
Cow's milk or egg allergy control low dose
Control Group 1: strict avoidance diet, excluding all milk or egg (as appropriate) and any foods containing them.
No interventions assigned to this group
Dietary intervention with cow's milk or egg baked cookies high dose
Baked Group 2: continue a daily high dose of baked milk (0.55 g of milk protein) or baked egg (1.1 g of egg protein).
Dietary intervention with cow's milk or egg baked cookies high dose
Baked Group 2: continued a daily high dose of baked milk (0.55 g of milk protein or 1.1g egg protein) for 6 months. An increase dose is given at that time (1.1g cow's milk or 2g egg protein).
Tolerance to baked cow's milk or egg.
Avoidance
No interventions assigned to this group
Interventions
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Dietary intervention using cookies containing milk or egg low dose.
Baked Group 1: consumed a daily fixed low dose of baked milk or egg (0.0375 g of milk protein or 0.11 g of egg protein) for 6 months, followed by an additional increase at that time (0.075 g or 0.22 g).
Dietary intervention with cow's milk or egg baked cookies high dose
Baked Group 2: continued a daily high dose of baked milk (0.55 g of milk protein or 1.1g egg protein) for 6 months. An increase dose is given at that time (1.1g cow's milk or 2g egg protein).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Ongoing consumption of baked milk or egg goods
12 Months
6 Years
ALL
No
Sponsors
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Hospital Sant Joan de Deu
OTHER
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Principal Investigators
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Montserrat Alvaro, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sant Joan de Deu
Locations
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Barcelona
Esplugues de Llobregat, Barcelona, Spain
Countries
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References
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Muraro A, Roberts G, Clark A, Eigenmann PA, Halken S, Lack G, Moneret-Vautrin A, Niggemann B, Rance F; EAACI Task Force on Anaphylaxis in Children. The management of anaphylaxis in childhood: position paper of the European academy of allergology and clinical immunology. Allergy. 2007 Aug;62(8):857-71. doi: 10.1111/j.1398-9995.2007.01421.x. Epub 2007 Jun 21.
Leonard SA, Caubet JC, Kim JS, Groetch M, Nowak-Wegrzyn A. Baked milk- and egg-containing diet in the management of milk and egg allergy. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):13-23; quiz 24. doi: 10.1016/j.jaip.2014.10.001.
Kim JS, Nowak-Wegrzyn A, Sicherer SH, Noone S, Moshier EL, Sampson HA. Dietary baked milk accelerates the resolution of cow's milk allergy in children. J Allergy Clin Immunol. 2011 Jul;128(1):125-131.e2. doi: 10.1016/j.jaci.2011.04.036. Epub 2011 May 23.
Lambert R, Grimshaw KEC, Ellis B, Jaitly J, Roberts G. Evidence that eating baked egg or milk influences egg or milk allergy resolution: a systematic review. Clin Exp Allergy. 2017 Jun;47(6):829-837. doi: 10.1111/cea.12940. Epub 2017 May 17.
Anagnostou A, Mack DP, Johannes S, Shaker M, Abrams EM, DeSanto K, Greenhawt M. The Safety and Efficacy of Baked Egg and Milk Dietary Advancement Therapy: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol Pract. 2024 Sep;12(9):2468-2480. doi: 10.1016/j.jaip.2024.06.016. Epub 2024 Jun 18.
Warren CM, Jiang J, Gupta RS. Epidemiology and Burden of Food Allergy. Curr Allergy Asthma Rep. 2020 Feb 14;20(2):6. doi: 10.1007/s11882-020-0898-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PIC-104-14
Identifier Type: -
Identifier Source: org_study_id
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