Early Supplementation for Cow's Milk Allergy Prevention
Launched by MEDICAL UNIVERSITY OF WARSAW · Oct 21, 2024
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether introducing different types of cow's milk formulas or human milk soon after birth can help prevent cow's milk allergy (CMA) in infants. CMA is a common allergy that can affect a child's diet and overall quality of life. The researchers want to find out if giving healthy newborns cow's milk formula, amino acids formula, donor human milk, or specially processed donor milk shortly after birth can lower the chance of developing this allergy later on.
To be eligible for this trial, infants must be healthy, full-term babies born to mothers who plan to exclusively breastfeed for the first six months, and they should be enrolled within 24 hours of birth. Infants with serious health issues or those whose parents plan to use formula feeding are not eligible. Participants will receive one of the study formulas and will be monitored throughout the trial to see how their bodies respond. This research aims to provide clearer guidelines on how early exposure to cow's milk proteins might help protect against CMA, ultimately benefiting many families.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
- • 2. Full-term infants (defined as gestational age of at least 37 weeks)
- • 3. Infant birth weight at least 2500 g and ≤ 4500 g
- • 4. Age at enrolment \<24 h of life
- • 5. Regardless of any atopic condition in parents
- • 6. Written informed consent of the caregiver
- Exclusion criteria:
- • 1. Infants of parents who intend to partially or fully formula feed
- • 2. 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
- • 3. Contradictions to exclusive breastfeeding
- • 4. Multiple pregnancy
About Medical University Of Warsaw
The Medical University of Warsaw is a leading academic institution dedicated to advancing healthcare through innovative research and education. Renowned for its commitment to excellence in medical training and clinical practice, the university actively engages in a diverse range of clinical trials aimed at improving patient outcomes and enhancing medical knowledge. With a robust infrastructure and a multidisciplinary team of experts, the Medical University of Warsaw fosters collaboration in the development of novel therapies and interventions, contributing significantly to the global medical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warsaw, Masovian, Poland
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported