Food AllergyGOALNCT07795957
GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
A study testing oral food challenge (OFC) in people with Food Allergy and Cow's Milk Protein Allergy, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Food Allergy, Cow's Milk Protein Allergy, Cow's Milk Allergy
- What is being tested?
- oral food challenge (OFC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Jan 2027to 2 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 1 and 5 years.
- Diagnosis of IgE-mediated CMA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis occurring more than 6 months before enrolment) diagnosis may be established without a new OFC, based on a positive SPT wheal at least 3 mm greater than negative saline control and elevated specific IgE to CMPs >0.35 kUa/L.
- On a cow's milk-free, therapeutic elimination diet for at least 6 months, or since before 12 months of age.
- Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
- Overall good health status.
- Parents/legal guardians able to understand the study procedures and communicate effectively with the study team.
- Written informed consent provided by parents/legal guardians.
- Expected good cooperation of the child's parents/legal guardians with the study team.
Who cannot join
- Uncontrolled asthma, defined as poor control according to the current GINA criteria, recent exacerbation requiring systemic corticosteroids or the need for medium to high-dose inhaled corticosteroids to maintain control
- Signs of acute infectious disease (i.e., acute runny nose, cough, or fever).
- Clinically relevant, uncontrolled exacerbation of another allergic disease that, in the investigator's judgement, could compromise OFC interpretation or safety (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).
- History of anaphylaxis due to cow's milk proteins within the last 6 months.
- Use of antihistamines within 3-10 days before the OFC, depending on the drug's pharmacokinetics and indication (time-limited contradiction - relative exclusion criterion).
- Documented tolerance to baked CMPs or to higher steps of the milk ladder.
- Use of immunosuppressive drugs or ongoing allergen immunotherapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, Łódź, Poland
Lodz
Medical Univeristy of Warsaw, Department of Paediatrics
Warsaw
Andrea Horvath, MD, Professor, 048 22 317 94 44, andrea.horvath@wum.edu.pl
Katarzyna Konieczek, MD, 048 22 317 95 35, katarzyna.konieczek@wum.edu.pl
About this study
Official title: Efficacy and Safety of a Four-step Goat Milk Formula-based Ladder Versus a Four-step Cow's Milk Ladder in Children With IgE-mediated Cow's Milk Allergy: Protocol for the Exploratory GOAL Randomised Controlled Trial.
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. This study will compare a four-step goat milk formula-based ladder (4-GMFL) with a four-step cow's milk ladder (4-CML).
This exploratory open-label, multicentre, randomised trial will enroll 92 children aged 1-5 years with IgE-mediated CMA, allocated 1:1 to the 4-GMFL or 4-CML group. Both ladders comprise muffin, pancake and baked hard cheese, introduced at 4-week intervals and assessed by open, physician-supervised oral food challenges (OFCs) in hospital, followed by a final OFC with 120 mL of non-heated pasteurised cow's milk at week 12.
The primary outcome will be tolerance to non-heated cow's milk protein at this final step, defined as a negative OFC with 120 mL of pasteurised cow's milk containing 3.96 g of protein. Secondary outcomes will include tolerance to individual ladder products, allergic reactions, anaphylaxis, intramuscular adrenaline use, anthropometric changes, food allergy-related quality of life, caregiver anxiety and adherence. Molecular sensitisation profiles will be explored as potential predictors of OFC outcomes.
Read the detailed description
Goat's milk differs from cow's milk in casein composition, protein structure and digestibility. Recent data suggest that these differences may modify IgE recognition and allergenic potential. This study is based on the hypothesis that repeated exposure to goat milk formula-containing products may provide a different pattern of allergen exposure from that achieved with a conventional cow's milk ladder.
This study aims to assess the effectiveness and safety of the 4-step goat milk formula-based ladder (4-GMFL) compared to the 4-step cow's milk ladder (4-CML) in children with IgE-mediated cow's milk allergy.
An exploratory open-label randomised trial with two parallel arms in two departments: the Department of Paediatrics, Medical University of Warsaw, and the Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, will be performed. A total of 92 children with IgE-mediated cow's milk allergy will be allocated to introduce cow's milk into their diet according to either 4-GMFL or 4-CML with a 4-week break period between subsequent steps. Oral food challenge (OFCs) with tested products - muffin with goat or cow's milk formula, pancake with goat or cow's milk formula, baked goat or cow's milk hard cheese, pasteurised cow's milk - at each subsequent steps of the ladders will be conducted in hospital settings. In both groups, the final 4th ladder step is identical and will assess whether tolerance to the assigned ladder products is accompanied by tolerance to cow's milk protein.
The primary outcome will be the between-group difference in the proportion of children who acquire tolerance to non-heated pasteurised cow's milk, as determined by a negative OFC at the final step of the 4-GMFL or 4-CML. Cow's milk will be administered at the end of the observation period (12 weeks). The challenge dose will consist of 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein.
Secondary outcomes will include between-group difference in the proportion of children with negative OFCs to each ladder steps; between-group difference in the percentage of children with anaphylaxis who required epinephrine administration; between-group difference in the percentage of children with exacerbation of atopic dermatitis; growth; compliance; Food Allergy Quality of Child's Life and the caregivers and parents' anxiety about adverse events during their child's OFC.
The statistical analyses will be conducted with StatsDirect. The Mann-Whitney U test will be used to compare the means of continuous variables if non-normal distribution will be assessed. Proportions will be compared with the Fisher exact test. The difference in study groups was considered significant when the P value will be <05. The results of this study will be analyzed on the basis of intention to treat.
- Conditions
- Food Allergy, Cow's Milk Protein Allergy, Cow's Milk Allergy
- Being tested
- oral food challenge (OFC)
- Keywords
- IgE-mediated cow's milk allergy, children, milk ladder, goat milk formula
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral food challenge (OFC)Other
oral food challenges with subsequent steps of a 4-step goat milk formula-based ladder (muffin prepared with goat milk formula, pancake prepared with goat milk formula, baked goat hard cheese, pasteurised cow's milk)
oral food challenge (OFC)Other
oral food challenges with subsequent steps of a 4-step cow's milk ladder (muffin prepared with cow's milk, pancake prepared with cow's milk, baked cow's milk hard cheese, pasteurised cow's milk)
| Study group | Role | What they receive |
|---|---|---|
| 4-step Goat Milk Formula-Based Ladder | Experimental | Not described Receives: Other: oral food challenge (OFC) |
| 4-step Cow's Milk Ladder | Active comparator | Not described Receives: Other: oral food challenge (OFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk
The primary outcome will be the between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk.
Tolerance will be defined as the absence of an allergic reaction during an OFC with 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein. In both the 4-CML and 4-GMFL groups, this OFC constitutes Step 4 and the final step of the ladder.
Measured: Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).
Secondary outcomes (9)
Between-group difference in the proportion of children tolerating the full predefined dose at Steps 1-3
Proportion of participants in each study arm who tolerate the full predefined dose of the ladder products during the OFCs at the first three steps: muffin at baseline, pancake at week 4, baked hard cheese at week 8.
Measured: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in maximum tolerated dose at each ladder step
Maximum tolerated dose of each ladder product during Steps 1-3, expressed both as the absolute amount of the study product and the corresponding milk protein dose.
Measured: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in the percentage of children who experienced anaphylaxis
Between-group difference in the proportion of children who experience anaphylaxis defined as reactions with severity grades 3-5 according to the updated 2023 WAO clinical criteria for anaphylaxis.
Measured: Measured during the observation period (12 weeks).
Between-group difference in the proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration
Between-group difference in the proportion of children who experienced anaphylaxis and required epinephrine will be reported in three categories:
- those who require one or two doses of intramuscular epinephrine with a good clinical response (less severe reaction, grade 3),
- those who require more than 2 doses of intramuscular epinephrine,
- those with lack of significant clinical improvement after two doses (severe reactions, grades 4-5).
Measured: Measured during the observation period (12 weeks).
Between-group differences in anthropometric changes
Between-group differences in the change in BMI-for-age z-score and length/height-for-age z-score, evaluated using the WHO growth charts.
Measured: Measured during the observation period (12 weeks).
Between-group difference in the change in the total score of the FAQLQ-PF
The questionnaire is divided into three domains: emotional impact, food anxiety, and social and dietary limitations. The total score is calculated as the mean of three subscales. The minimum score is 0, the maximum score is 6. The lower the score, the more life affecting the allergy is.
Measured: At the end of the observation period (12 weeks) from baseline.
Between-group differences in caregiver anxiety levels, measured by the Subjective Units of Distress Scale (SUDS)
Parents will rate their level of anxiety on a scale from 1 to 100, where 0 represents no anxiety or complete relaxation, and 100 represents extreme anxiety, the worst ever experienced.
Measured: Before each OFC at baseline, week 4, week 8 and week 12
Between-group difference in full adherence to the intervention protocol
Between-group difference in the proportion of children with full adherence to the intervention protocol, defined as completion of all scheduled OFCs and home administration of the most recently tolerated ladder product in the prescribed form and dose at least three times per week.
Data will be collected through the paper-based Milk Ladder Monitoring Diary during home administration (between the following steps of each ladder).
Measured: At the end of the observation period (12 weeks).
In the subgroup of children with atopic dermatitis, changes in the total score of the oSCORAD index will be assessed before and after each OFC.
The maximum score on the oSCORAD scale is 83 points (in the most severe cases, an additional 10 points can be added for changes that disfigure or limit the patient's functioning), the minimum score is 0 points; the more points, the greater intensity of changes. Any documented exacerbation of atopic dermatitis symptoms following OFC will be also recorded.
Measured: Upon completion of the observation period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start2 Jan 2027 (estimated)
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lublin, NYU Langone Health, University of Warmia and Mazury in Olsztyn, Medical University of Lodz
- Responsible party
- Principal investigator, Andrea Horvath-Stolarczyk, Medical University of Warsaw
- Investigators
- Hanna Szajewska, MD, Professor, Principal investigator, Medical University of WarsawAnna Nowak-Węgrzyn, MD, Professor, Principal investigator, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of MedicineAndrea Horvath, MD, Professor, Principal investigator, Medical Univeristy of WarsawJoanna Jerzyńska, MD, PhD, Principal investigator, Medical Univeristy of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795957
- Sponsor's protocol ID
- GOAL2026
- Acronym
- GOAL
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this RCT, whether positive or negative, will be published in a peer-reviewed journal (data will be submitted to the first journal after 3-6 months from study completion). Abstracts will also be submitted to relevant national and international conferences. The datasets used and/or generated during this study will be made available from a given author upon reasonable request, after the publication of results, no later than 3 years from the completion of data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Four-step Goat Milk Formula-based Ladder Versus a Four-step Cow's Milk Ladder in Children With IgE-mediated Cow's Milk Allergy: Protocol for the Exploratory GOAL Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07795957
- Acronym / sponsor ID
- GOAL / GOAL2026
- Conditions
- Food Allergy, Cow's Milk Protein Allergy, Cow's Milk Allergy
- Keywords
- IgE-mediated cow's milk allergy, children, milk ladder, goat milk formula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical University of Lublin, NYU Langone Health, University of Warmia and Mazury in Olsztyn, Medical University of Lodz
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 31 Aug 2026 (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.
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination. Preliminary observations suggest that some may tolerate products prepared with a low-αs1-casein goat milk formula. This study will compare a four-step goat milk formula-based ladder (4-GMFL) with a four-step cow's milk ladder (4-CML).
This exploratory open-label, multicentre, randomised trial will enroll 92 children aged 1-5 years with IgE-mediated CMA, allocated 1:1 to the 4-GMFL or 4-CML group. Both ladders comprise muffin, pancake and baked hard cheese, introduced at 4-week intervals and assessed by open, physician-supervised oral food challenges (OFCs) in hospital, followed by a final OFC with 120 mL of non-heated pasteurised cow's milk at week 12.
The primary outcome will be tolerance to non-heated cow's milk protein at this final step, defined as a negative OFC with 120 mL of pasteurised cow's milk containing 3.96 g of protein. Secondary outcomes will include tolerance to individual ladder products, allergic reactions, anaphylaxis, intramuscular adrenaline use, anthropometric changes, food allergy-related quality of life, caregiver anxiety and adherence. Molecular sensitisation profiles will be explored as potential predictors of OFC outcomes.
Detailed description
Goat's milk differs from cow's milk in casein composition, protein structure and digestibility. Recent data suggest that these differences may modify IgE recognition and allergenic potential. This study is based on the hypothesis that repeated exposure to goat milk formula-containing products may provide a different pattern of allergen exposure from that achieved with a conventional cow's milk ladder.
This study aims to assess the effectiveness and safety of the 4-step goat milk formula-based ladder (4-GMFL) compared to the 4-step cow's milk ladder (4-CML) in children with IgE-mediated cow's milk allergy.
An exploratory open-label randomised trial with two parallel arms in two departments: the Department of Paediatrics, Medical University of Warsaw, and the Department of Paediatrics and Allergy, Copernicus Memorial Hospital, Medical University of Lodz, will be performed. A total of 92 children with IgE-mediated cow's milk allergy will be allocated to introduce cow's milk into their diet according to either 4-GMFL or 4-CML with a 4-week break period between subsequent steps. Oral food challenge (OFCs) with tested products - muffin with goat or cow's milk formula, pancake with goat or cow's milk formula, baked goat or cow's milk hard cheese, pasteurised cow's milk - at each subsequent steps of the ladders will be conducted in hospital settings. In both groups, the final 4th ladder step is identical and will assess whether tolerance to the assigned ladder products is accompanied by tolerance to cow's milk protein.
The primary outcome will be the between-group difference in the proportion of children who acquire tolerance to non-heated pasteurised cow's milk, as determined by a negative OFC at the final step of the 4-GMFL or 4-CML. Cow's milk will be administered at the end of the observation period (12 weeks). The challenge dose will consist of 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein.
Secondary outcomes will include between-group difference in the proportion of children with negative OFCs to each ladder steps; between-group difference in the percentage of children with anaphylaxis who required epinephrine administration; between-group difference in the percentage of children with exacerbation of atopic dermatitis; growth; compliance; Food Allergy Quality of Child's Life and the caregivers and parents' anxiety about adverse events during their child's OFC.
The statistical analyses will be conducted with StatsDirect. The Mann-Whitney U test will be used to compare the means of continuous variables if non-normal distribution will be assessed. Proportions will be compared with the Fisher exact test. The difference in study groups was considered significant when the P value will be <05. The results of this study will be analyzed on the basis of intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-step Goat Milk Formula-Based Ladder | Experimental | Other: oral food challenge (OFC) |
| 4-step Cow's Milk Ladder | Active comparator | Other: oral food challenge (OFC) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 1 and 5 years.
- Diagnosis of IgE-mediated CMA confirmed according to ESPGHAN guidelines, by a positive OFC with CMPs. In high-risk children (i.e., with a history of anaphylaxis occurring more than 6 months before enrolment) diagnosis may be established without a new OFC, based on a positive SPT wheal at least 3 mm greater than negative saline control and elevated specific IgE to CMPs >0.35 kUa/L.
- On a cow's milk-free, therapeutic elimination diet for at least 6 months, or since before 12 months of age.
- Eligible regardless of the risk of systemic reaction (anaphylaxis) and asthma.
- Overall good health status.
Key exclusion criteria (7 listed)
- Uncontrolled asthma, defined as poor control according to the current GINA criteria, recent exacerbation requiring systemic corticosteroids or the need for medium to high-dose inhaled corticosteroids to maintain control
- Signs of acute infectious disease (i.e., acute runny nose, cough, or fever).
- Clinically relevant, uncontrolled exacerbation of another allergic disease that, in the investigator's judgement, could compromise OFC interpretation or safety (i.e., conjunctivitis, allergic rhinitis, atopic dermatitis).
- History of anaphylaxis due to cow's milk proteins within the last 6 months.
- Use of antihistamines within 3-10 days before the OFC, depending on the drug's pharmacokinetics and indication (time-limited contradiction - relative exclusion criterion).
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 |
|---|---|---|
| oral food challenge (OFC)oral food challenges with subsequent steps of a 4-step goat milk formula-based ladder (muffin prepared with goat milk formula, pancake prepared with goat milk formula, baked goat hard cheese, pasteurised cow's milk) | Other | 4-step Goat Milk Formula-Based Ladder |
| oral food challenge (OFC)oral food challenges with subsequent steps of a 4-step cow's milk ladder (muffin prepared with cow's milk, pancake prepared with cow's milk, baked cow's milk hard cheese, pasteurised cow's milk) | Other | 4-step Cow's Milk Ladder |
Primary outcome
Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk
Time frame: Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).
The primary outcome will be the between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk. Tolerance will be defined as the absence of an allergic reaction during an OFC with 120 mL of pasteurised cow's milk, corresponding to 3.96 g of cow's milk protein. In both the 4-CML and 4-GMFL groups, this OFC constitutes Step 4 and the final step of the ladder.
9 secondary outcomes
Between-group difference in the proportion of children tolerating the full predefined dose at Steps 1-3
Time frame: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in maximum tolerated dose at each ladder step
Time frame: Baseline (Step 1), week 4 (Step 2) and week 8 (Step 3)
Between-group difference in the percentage of children who experienced anaphylaxis
Time frame: Measured during the observation period (12 weeks).
Between-group difference in the proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration
Time frame: Measured during the observation period (12 weeks).
Between-group differences in anthropometric changes
Time frame: Measured during the observation period (12 weeks).
Between-group difference in the change in the total score of the FAQLQ-PF
Time frame: At the end of the observation period (12 weeks) from baseline.
Between-group differences in caregiver anxiety levels, measured by the Subjective Units of Distress Scale (SUDS)
Time frame: Before each OFC at baseline, week 4, week 8 and week 12
Between-group difference in full adherence to the intervention protocol
Time frame: At the end of the observation period (12 weeks).
In the subgroup of children with atopic dermatitis, changes in the total score of the oSCORAD index will be assessed before and after each OFC.
Time frame: Upon completion of the observation period (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. The results of this RCT, whether positive or negative, will be published in a peer-reviewed journal (data will be submitted to the first journal after 3-6 months from study completion). Abstracts will also be submitted to relevant national and international conferences. The datasets used and/or generated during this study will be made available from a given author upon reasonable request, after the publication of results, no later than 3 years from the completion of data analysis.
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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.
Hanna Szajewska, MD, Professor principal investigator
Medical University of Warsaw
Anna Nowak-Węgrzyn, MD, Professor principal investigator
Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine
Andrea Horvath, MD, Professor principal investigator
Medical Univeristy of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral food challenge (OFC) in people with Food Allergy and Cow's Milk Protein Allergy, run by Medical University of Warsaw at 2 sites in Poland.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Horvath, MD, Professor (048 22 317 94 44, andrea.horvath@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in the proportion of children who tolerate non-heated pasteurised cow's milk (time frame: Non-heated pasteurised cow's milk will be administered at the end of the observation period (week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.