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Early Supplementation for Cow's Milk Allergy Prevention

ConditionsFood AllergyCow's Milk Allergy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorMedical University of Warsaw

About this 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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Cow's milk formula [CMF]

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: CMFExperimental treatment 1 intervention
Group B: AAFExperimental treatment 1 intervention
Group C: DHMExperimental treatment 1 intervention
Group D: DHM-PExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At 4-6 and 12 months of age

Secondary outcomes

1

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
2

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

Time frame
at 4-6, and 12 months of age
3

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
4

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.

Time frame
at 9 and/or 12 months

Other outcomes

Sponsors and contacts

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Medical University of Warsaw

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: