Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
Launched by HEINZ ITALIA SPA · Sep 8, 2010
Trial Information
Current as of August 19, 2025
Completed
Keywords
ClinConnect Summary
Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.
New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.
The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.
The aim of this study is to verify the safety of the study formula in healthy term infants and to ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Infants of both sexes born to natural or cesarean delivery
- • Gestational age between 37 and 42 completed weeks
- • Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
- • Single birth
- • Caucasian parents
- • Infants being exclusively formula-fed by the 21st day of life
- Exclusion Criteria:
- • Infants with genetic and/or congenital diseases
- • Infants receiving antibiotic therapy
- • Infants with neonatal diseases requiring hospitalisation for longer than 7 days
- • Infants at risk for atopy and/or having familial history for atopy
- • Mothers with metabolic or chronic diseases
- • Infant selected for another clinical study
- • Parents refusing to sign a written informed consent
About Heinz Italia Spa
Heinz Italia S.p.A., a subsidiary of the global food corporation Kraft Heinz, is dedicated to delivering high-quality food products while prioritizing innovation and consumer health. With a strong commitment to research and development, Heinz Italia actively engages in clinical trials to explore the health benefits of its food offerings and contribute to nutritional science. The company aims to enhance the dietary habits of consumers through scientifically-backed initiatives, ensuring that their products meet the evolving needs of health-conscious individuals. Through its rigorous clinical research efforts, Heinz Italia strives to foster a deeper understanding of food's role in health and wellness.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pavia, Pv, Italy
Patients applied
Trial Officials
Mauro Stronati, Prof.
Principal Investigator
FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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