Cow Milk Protein AllergyBFTNCT06998225
Tolerance to Baked Goods in Allergic Children
A study testing Dietary intervention using cookies containing milk or egg low dose. and Dietary intervention with cow's milk or egg baked cookies high dose in people with Cow Milk Protein Allergy and Hen Egg Allergy, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Cow Milk Protein Allergy, Hen Egg Allergy
- What is being tested?
- Dietary intervention using cookies containing milk or egg low dose. and Dietary intervention with cow's milk or egg baked cookies high dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2016to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with confirmed allergy to cow's milk or cooked egg
Who cannot join
- Contraindication to epinephrine use
- Ongoing consumption of baked milk or egg goods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance to Baked Goods in Children Under 5 Years Allergic to Cow's Milk or Egg Proteins
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.
Read more
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.
Read the detailed description
This is a 12-month, prospective, randomized interventional study designed to evaluate immunological tolerance development in young children with confirmed cow's milk or egg allergy. The primary endpoint is the acquisition of clinical tolerance to raw or minimally processed forms of the allergen after structured dietary exposure to baked forms. The study integrates immunologic, clinical, and laboratory evaluations to assess the therapeutic potential and immunomodulatory effects of gradual allergen introduction.
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:
- 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.
- 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
- Cow Milk Protein Allergy, Hen Egg Allergy
- Being tested
- Dietary intervention using cookies containing milk or egg low dose., Dietary intervention with cow's milk or egg baked cookies high dose
- Keywords
- baked food tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 high doseDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from enrollment
Secondary outcomes (3)
Change in immunologic markers (IgE, IgG4, Tregs, BAT).
Longitudinal changes in immunological biomarkers (specific IgE, IgG4, Tregs, and BAT) over the 12-month study period. The measurements of the biomarkers obtained initially (T0) and after the intervention (T1) were compared, observing a reduction in specific IgE and an increase in IgG4 in the tolerant patients. The BAT has also shown changes in the intervention but the statistical significance must be individualized by food. T-cell cytokine profiling in patients with cow's milk allergy showed no significant changes. Analysis for the egg allergy group is pending.
Measured: 12 months intervention
Rate of reactions during oral food challenges.
Number and severity of reactions recorded during oral food challenge procedures were obtained T0 and T1. The severity of reactions were classified according to the EACCI position paper 2007.
Measured: 12 months intervention
Changes in threshold dose triggering reactions.
Variation in the minimum eliciting dose (MED) triggering allergic symptoms in the OFC at T1 was evaluated. An increase in the tolerated allergen dose without a clinical reaction indicates a higher reaction threshold-dose, and this was assessed as favorable after the intervention. This condition would allow the participant to follow a less restrictive diet and, consequently, less concern about food safety.
Measured: 12 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jun 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cow Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Sponsor
- Investigators
- Montserrat Alvaro, PhD, MD, Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998225
- Sponsor's protocol ID
- PIC-104-14
- Acronym
- BFT
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following individual participant data will be shared: demographic data (age, sex), clinical outcomes (primary and secondary endpoints), laboratory results, and adverse events. Data will be available beginning 6 months after publication and will remain accessible for 5 years. Data will be shared with qualified researchers affiliated with academic or healthcare institutions, for purposes of academic research or meta-analysis, and can be used for further analysis of the intervention's efficacy, safety profiling, or inclusion in systematic reviews. Study protocol, statistical analysis plan, and informed consent forms (in anonymized format) will also be made available. Requests should be submitted to the corresponding author by email. A data access agreement must be signed, and the research proposal will be reviewed by the study steering committee before approval is granted.
Publications
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.
PubMed 17590200Leonard 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.
PubMed 25577613Kim 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.
PubMed 21601913Lambert 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.
PubMed 28516451Anagnostou 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.
PubMed 38901613Warren 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.
PubMed 32067114
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance to Baked Goods in Children Under 5 Years Allergic to Cow's Milk or Egg Proteins
- ClinicalTrials.gov ID
- NCT06998225
- Acronym / sponsor ID
- BFT / PIC-104-14
- Conditions
- Cow Milk Protein Allergy, Hen Egg Allergy
- Keywords
- baked food tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a 12-month, prospective, randomized interventional study designed to evaluate immunological tolerance development in young children with confirmed cow's milk or egg allergy. The primary endpoint is the acquisition of clinical tolerance to raw or minimally processed forms of the allergen after structured dietary exposure to baked forms. The study integrates immunologic, clinical, and laboratory evaluations to assess the therapeutic potential and immunomodulatory effects of gradual allergen introduction.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention with cow's milk or egg baked cookies low dose | Active comparator | Dietary Supplement: Dietary intervention using cookies containing milk or egg 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). |
| 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 | Dietary Supplement: Dietary intervention with cow's milk or egg baked cookies high doseBaked 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). |
| Tolerance to baked cow's milk or egg. | No intervention | –Avoidance |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with confirmed allergy to cow's milk or cooked egg
Key exclusion criteria (2 listed)
- Contraindication to epinephrine use
- Ongoing consumption of baked milk or egg goods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 supplement | Dietary intervention with cow's milk or egg baked cookies low dose |
| Dietary intervention with cow's milk or egg baked cookies high doseBaked 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 supplement | Dietary intervention with cow's milk or egg baked cookies high dose |
Primary outcome
1. To evaluate proportion of children who develop tolerance to raw milk or cooked/raw egg at 12 months.
Time frame: 12 months from enrollment
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.
3 secondary outcomes
Change in immunologic markers (IgE, IgG4, Tregs, BAT).
Time frame: 12 months intervention
Rate of reactions during oral food challenges.
Time frame: 12 months intervention
Changes in threshold dose triggering reactions.
Time frame: 12 months intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Results publication: PubMed 17590200Muraro 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.
- Results publication: PubMed 25577613Leonard 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.
- Results publication: PubMed 21601913Kim 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.
- Results publication: PubMed 28516451Lambert 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.
- Results publication: PubMed 38901613Anagnostou 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.
- Results publication: PubMed 32067114Warren 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.
- Individual participant dataSharing planned: Yes. The following individual participant data will be shared: demographic data (age, sex), clinical outcomes (primary and secondary endpoints), laboratory results, and adverse events. Data will be available beginning 6 months after publication and will remain accessible for 5 years. Data will be shared with qualified researchers affiliated with academic or healthcare institutions, for purposes of academic research or meta-analysis, and can be used for further analysis of the intervention's efficacy, safety profiling, or inclusion in systematic reviews. Study protocol, statistical analysis plan, and informed consent forms (in anonymized format) will also be made available. Requests should be submitted to the corresponding author by email. A data access agreement must be signed, and the research proposal will be reviewed by the study steering committee before approval is granted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Alvaro, PhD, MD principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention using cookies containing milk or egg low dose. and Dietary intervention with cow's milk or egg baked cookies high dose in people with Cow Milk Protein Allergy and Hen Egg Allergy, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To evaluate proportion of children who develop tolerance to raw milk or cooked/raw egg at 12 months. (time frame: 12 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998225, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.