Early Supplementation for Cow's Milk Allergy Prevention

NCT06652698 | Not Yet Recruiting DMC

• 1 other identifier: ABM30
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Food Allergy; Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• A cumulative incidence of cow's milk allergy confirmed by open oral food challenge

  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

  at 6 and 12 months of age

• A point prevalence of cow's milk allergy confirmed by open oral food challenge

  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)

  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

  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

  Up to 4 month of age

Study Arms (4)

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]

Interventions

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.

CMF

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.

AAF

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.

DHM

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.

DHM-P

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (1)

• 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.

  PMID: 40764079 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Interventions

CMF regimen; 2-Acetylaminofluorene

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Andrea Horvath, Assoc Prof, MD

  Medical University of Warsaw

  STUDY CHAIR

• Aleksandra Wesołowska, Assoc Prof

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Hanna Szajewska, Prof, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Horvath, Assoc Prof

CONTACT

22 317 9444; andrea.horvath@wum.edu.pl

Study Design

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

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: October 22, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After the publication of results, no later than 3 years from the completion of data analysis.
• Access Criteria: The anonymized datasets used and/or gener.ated during this study will be made available from a corresponding author on reasonable request

Locations

PL (1)