Food AllergyESCAPE-PLNCT06652698
Early Supplementation for Cow's Milk Allergy Prevention
A study testing Cow's milk formula [CMF], Amino-acid formula [AAF] and Donor human milk [DHM] in people with Food Allergy and Cow's Milk Allergy, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Cow's Milk Allergy
- What is being tested?
- Cow's milk formula [CMF], Amino-acid formula [AAF] and Donor human milk [DHM]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2025to Mar 2031
- 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 Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
- Full-term infants (defined as gestational age of at least 37 weeks)
- Infant birth weight at least 2500 g and ≤ 4500 g
- Age at enrolment <24 h of life
- Regardless of any atopic condition in parents
- Written informed consent of the caregiver
Who cannot join
- Infants of parents who intend to partially or fully formula feed
- Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth
- Contradictions to exclusive breastfeeding
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Andrea Horvath, Assoc Prof, 22 317 9444, andrea.horvath@wum.edu.pl
About this study
Official title: Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial
Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.
There is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.
Read more
This trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula [CMF], amino acids formula [AAF], donor human milk [DHM], or high-pressure processed "pascalized" donor human milk [DHM-P]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.
This study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.
- Conditions
- Food Allergy, Cow's Milk Allergy
- Being tested
- Cow's milk formula [CMF], Amino-acid formula [AAF], Donor human milk [DHM], High-pressure processed "pascalized" donor human milk [DHM-P]
- 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.
Cow's milk formula [CMF]Other
At least 10 ml daily of cow's milk formula (Bebiko 1 NUTRIFlor Expert®, Nutricia; formula with galactooligosaccharides and without probiotics); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
Amino-acid formula [AAF]Other
At least 10 ml daily of amino-acid formula (Nutramigen Pureamino®, Reckitt Benckiser Group PLC); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
Donor human milk [DHM]Other
At least 10 ml daily of donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
High-pressure processed "pascalized" donor human milk [DHM-P]Other
At least 10 ml daily of high-pressure processed "pascalized" donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided.
| Study group | Role | What they receive |
|---|---|---|
| CMF | Experimental | Not described Receives: Other: Cow's milk formula [CMF] |
| AAF | Experimental | Not described Receives: Other: Amino-acid formula [AAF] |
| DHM | Experimental | Not described Receives: Other: Donor human milk [DHM] |
| DHM-P | Experimental | Not described Receives: Other: High-pressure processed "pascalized" donor human milk [DHM-P] |
What is being measured
The primary outcome is the main question the study is designed to answer.
A cumulative incidence of cow's milk allergy confirmed by open oral food challenge
Measured: At 4-6 and 12 months of age
Secondary outcomes (21)
A cumulative incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] and ≥3 mm of wheal size in the skin prick test against cow's milk
Measured: at 6 and 12 months of age
A point prevalence of cow's milk allergy confirmed by open oral food challenge
Measured: at 4-6, and 12 months of age
An incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] against cow's milk)
Measured: at 4-6, and 12 months of age
In a subgroup of children with confirmed cow's milk allergy, the percentage of children with tolerance acquisition to cow's milk
Tolerance acquisition to cow's milk will be assessed by subsequent OFC with baked milk (in the form of biscuit or muffin); if baked milk is tolerated, the assessment of tolerance acquisition will be continued with the use of milk ladder.
Measured: at 9 and/or 12 months
Percentage of children who received a full 3-day nutritional supplementation (3x10 ml according to the randomization) and then were exclusively or predominantly breastfed until 4 months of age
Measured: Up to 4 month of age
A total score in the Cow's Milk-related Symptom Score (CoMiSS)
The total CoMiSS score ranges from 0 to 33, a score of ≥10 indicates CMA.
Measured: at 4-6 and 12 months of age
Percentage of children exclusively breastfed
Measured: at 4 and 6 months of age
Percentage of children with mixed feeding
Measured: at 4 and 6 months of age
Change in Body Mass Index (BMI)-for-age z-score
weight and length will be checked each month in a telephone interview or parental report, or during follow-up visit assessed by study physician; change in mean value will be assessed between baseline and each time point
Measured: at 4, 6 and 12 months of age
Change in length-for-age z-score
length will be checked each month in a telephone interview or parental report, or during follow-up visit assessed by study physician; change in mean value will be assessed between baseline and each time point
Measured: at 4, 6 and 12 months of age
Adverse events related to the nutritional intervention (according to the randomization)
defined as any harmful events that may occur during the trial; the process of decision whether an adverse event is related to the intervention (attribution) will be made by the non-blinded principal investigator
Measured: up to 12 months of age
A cumulative incidence of atopic dermatitis (defined as meeting the UK Working Party diagnostic Criteria)
Measured: at 6 and 12 months of age
A cumulative incidence of allergic rhinitis (confirmed by study physician)
Measured: at 6 and 12 months of age
A cumulative incidence of feeding difficulties who will be screened with The Montreal Children's Hospital Feeding Scale (MCH-FS scale)
Total score range from 14 to 98, score of 46 or higher indicates feeding difficulties.
Measured: at 6 and 12 months of age
Human milk energy value (kcal/100 mL)
Measured: at 4-14 days postpartum and 6 months of age
Total and true protein concentrations in human milk samples (g/100 mL)
Measured: at 4-14 days postpartum and 6 months of age
Fat concentration in human milk samples (g/100 mL)
Measured: at 4-14 days postpartum and 6 months of age
Lactose concentration in human milk samples (g/100 mL)
Measured: at 4-14 days postpartum and 6 months of age
Dry mass content g/100 mL
Measured: at 4-14 days postpartum and 6 months of age
IgA-anty CMA concentration in human milk samples (pg/mL)
Measured: at 4-14 days postpartum
IL-1B, IL-6, IL-10, and TGF-beta concentrations in human milk samples (pg/mL)
Measured: at 4-14 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startJul 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Andrea Horvath, Assoc Prof, MD, Study chair, Medical University of WarsawAleksandra Wesołowska, Assoc Prof, Principal investigator, Medical University of WarsawHanna Szajewska, Prof, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652698
- Sponsor's protocol ID
- ABM30
- Acronym
- ESCAPE-PL
- Status last verified
- Mar 2025
- First submitted
- 23 Jul 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized datasets used and/or generated during this study will be made available from a corresponding author on reasonable request, after the publication of results, no later than 3 years from the completion of data analysis.
Publications
Horvath A, Wesolowska A, Strozyk A, Bzikowska-Jura A, Ambrozej D, Dumycz K, Feleszko W, Szajewska H. Early supplementation for cow's milk allergy prevention in breastfed infants in Poland (ESCAPE-PL): a protocol for randomised controlled trial. BMJ Open. 2025 Aug 5;15(8):e096217. doi: 10.1136/bmjopen-2024-096217.
PubMed 40764079
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Supplementation for Cow's Milk Allergy Prevention in Breastfed Infants in Poland (ESCAPE-PL): a Protocol for Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06652698
- Acronym / sponsor ID
- ESCAPE-PL / ABM30
- Conditions
- Food Allergy, Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 22 Oct 2024 (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.
Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.
There is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.
This trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula [CMF], amino acids formula [AAF], donor human milk [DHM], or high-pressure processed "pascalized" donor human milk [DHM-P]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.
This study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CMF | Experimental | Other: Cow's milk formula [CMF] |
| AAF | Experimental | Other: Amino-acid formula [AAF] |
| DHM | Experimental | Other: Donor human milk [DHM] |
| DHM-P | Experimental | Other: High-pressure processed "pascalized" donor human milk [DHM-P] |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
- Full-term infants (defined as gestational age of at least 37 weeks)
- Infant birth weight at least 2500 g and ≤ 4500 g
- Age at enrolment <24 h of life
- Regardless of any atopic condition in parents
Key exclusion criteria (4 listed)
- Infants of parents who intend to partially or fully formula feed
- Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth
- Contradictions to exclusive breastfeeding
- Multiple pregnancy
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 |
|---|---|---|
| Cow's milk formula [CMF]At least 10 ml daily of cow's milk formula (Bebiko 1 NUTRIFlor Expert®, Nutricia; formula with galactooligosaccharides and without probiotics); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided. | Other | CMF |
| Amino-acid formula [AAF]At least 10 ml daily of amino-acid formula (Nutramigen Pureamino®, Reckitt Benckiser Group PLC); and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided. | Other | AAF |
| Donor human milk [DHM]At least 10 ml daily of donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided. | Other | DHM |
| High-pressure processed "pascalized" donor human milk [DHM-P]At least 10 ml daily of high-pressure processed "pascalized" donor human milk; and if additional supplementation will be needed (i.e., insufficient, partial, or discontinuation of breastfeeding), the randomly assigned nutritional intervention until the end of 4 months of age will be provided. | Other | DHM-P |
Primary outcome
A cumulative incidence of cow's milk allergy confirmed by open oral food challenge
Time frame: At 4-6 and 12 months of age
21 secondary outcomes
A cumulative incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] and ≥3 mm of wheal size in the skin prick test against cow's milk
Time frame: at 6 and 12 months of age
A point prevalence of cow's milk allergy confirmed by open oral food challenge
Time frame: at 4-6, and 12 months of age
An incidence of sensitization to cow's milk protein (cut-off levels for specific IgE level ≥0.35 allergen units [UA/mL] against cow's milk)
Time frame: at 4-6, and 12 months of age
In a subgroup of children with confirmed cow's milk allergy, the percentage of children with tolerance acquisition to cow's milk
Time frame: at 9 and/or 12 months
Percentage of children who received a full 3-day nutritional supplementation (3x10 ml according to the randomization) and then were exclusively or predominantly breastfed until 4 months of age
Time frame: Up to 4 month of age
A total score in the Cow's Milk-related Symptom Score (CoMiSS)
Time frame: at 4-6 and 12 months of age
Percentage of children exclusively breastfed
Time frame: at 4 and 6 months of age
Percentage of children with mixed feeding
Time frame: at 4 and 6 months of age
Change in Body Mass Index (BMI)-for-age z-score
Time frame: at 4, 6 and 12 months of age
Change in length-for-age z-score
Time frame: at 4, 6 and 12 months of age
Adverse events related to the nutritional intervention (according to the randomization)
Time frame: up to 12 months of age
A cumulative incidence of atopic dermatitis (defined as meeting the UK Working Party diagnostic Criteria)
Time frame: at 6 and 12 months of age
A cumulative incidence of allergic rhinitis (confirmed by study physician)
Time frame: at 6 and 12 months of age
A cumulative incidence of feeding difficulties who will be screened with The Montreal Children's Hospital Feeding Scale (MCH-FS scale)
Time frame: at 6 and 12 months of age
Human milk energy value (kcal/100 mL)
Time frame: at 4-14 days postpartum and 6 months of age
Total and true protein concentrations in human milk samples (g/100 mL)
Time frame: at 4-14 days postpartum and 6 months of age
Fat concentration in human milk samples (g/100 mL)
Time frame: at 4-14 days postpartum and 6 months of age
Lactose concentration in human milk samples (g/100 mL)
Time frame: at 4-14 days postpartum and 6 months of age
Dry mass content g/100 mL
Time frame: at 4-14 days postpartum and 6 months of age
IgA-anty CMA concentration in human milk samples (pg/mL)
Time frame: at 4-14 days postpartum
IL-1B, IL-6, IL-10, and TGF-beta concentrations in human milk samples (pg/mL)
Time frame: at 4-14 days postpartum
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 17 Jul 2025.
- Derived from this study: PubMed 40764079Horvath A, Wesolowska A, Strozyk A, Bzikowska-Jura A, Ambrozej D, Dumycz K, Feleszko W, Szajewska H. Early supplementation for cow's milk allergy prevention in breastfed infants in Poland (ESCAPE-PL): a protocol for randomised controlled trial. BMJ Open. 2025 Aug 5;15(8):e096217. doi: 10.1136/bmjopen-2024-096217.
- Individual participant dataSharing planned: Yes. The anonymized datasets used and/or generated during this study will be made available from a corresponding author on 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.
Andrea Horvath, Assoc Prof, MD study chair
Medical University of Warsaw
Aleksandra Wesołowska, Assoc Prof principal investigator
Medical University of Warsaw
Hanna Szajewska, Prof, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk formula [CMF], Amino-acid formula [AAF] and Donor human milk [DHM] in people with Food Allergy and Cow's Milk Allergy, run by Medical University of Warsaw at 1 site 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 6 inclusion and 4 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 17 Jul 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 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, Assoc Prof (22 317 9444, 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?
A cumulative incidence of cow's milk allergy confirmed by open oral food challenge (time frame: At 4-6 and 12 months of age). 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 NCT06652698, which also lists 1 linked publication.
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 17 Jul 2025.