Tolerance to Baked Goods in Allergic Children

NCT06998225 | Completed DMC

• 1 other identifier: PIC-104-14
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Food allergies are more common in children, especially in Western countries. Around 5 to 8% of children have at least one food allergy, compared to only 1-2% of adults. These allergies can really affect child's quality of life and create stress for the whole family. The most common foods that cause allergic reactions are cow's milk, egg, nuts, fish, and shellfish. 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.

Conditions

Cow Milk Protein Allergy; Hen Egg Allergy

Keywords

baked food tolerance

Outcome Measures

Primary Outcomes (1)

• 1. To evaluate proportion of children who develop tolerance to raw milk or cooked/raw egg at 12 months.

  Proportion of participants who achieve clinical tolerance to raw cow's milk or cooked/raw egg following 12 months of intervention. All participants underwent a controlled oral food challenge (OFC) in day's hospital. The intervention will be evaluated positively if the participant become tolerant. An increase in the reaction threshold dose relative to the initial OFC will also be considered favorable. If symptoms appear immediately, the patient will be considered allergic.

  12 months from enrollment

Secondary Outcomes (3)

• Change in immunologic markers (IgE, IgG4, Tregs, BAT).

  12 months intervention

• Rate of reactions during oral food challenges.

  12 months intervention

• Changes in threshold dose triggering reactions.

  12 months intervention

Study Arms (4)

Dietary intervention with cow's milk or egg baked cookies low dose

ACTIVE COMPARATOR

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 Supplement: Dietary intervention using cookies containing milk or egg low dose.

Cow's milk or egg allergy control low dose

NO INTERVENTION

Control Group 1: strict avoidance diet, excluding all milk or egg (as appropriate) and any foods containing them.

Dietary intervention with cow's milk or egg baked cookies high dose

ACTIVE COMPARATOR

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 Supplement: Dietary intervention with cow's milk or egg baked cookies high dose

Tolerance to baked cow's milk or egg.

NO INTERVENTION

Avoidance

Interventions

Dietary intervention using cookies containing milk or egg low dose. DIETARY_SUPPLEMENT

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 low dose

Dietary intervention with cow's milk or egg baked cookies high dose DIETARY_SUPPLEMENT

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).

Dietary intervention with cow's milk or egg baked cookies high dose

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with confirmed allergy to cow's milk or cooked egg

You may not qualify if:

• Contraindication to epinephrine use
• Ongoing consumption of baked milk or egg goods

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

Barcelona

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (6)

• 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.

  PMID: 17590200 RESULT

• 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.

  PMID: 25577613 RESULT

• 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.

  PMID: 21601913 RESULT

• 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.

  PMID: 28516451 RESULT

• 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.

  PMID: 38901613 RESULT

• 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.

  PMID: 32067114 RESULT

MeSH Terms

Interventions

Eggs; Diet Therapy; Milk

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutrition Therapy; Therapeutics; Beverages; Dairy Products

Study Officials

• Montserrat Alvaro, PhD, MD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months after publication
• Access Criteria: Researchers affiliated with academic or healthcare institutions

Locations

ES (1)