Formula Feeding of Healthy Full Term Infants Clinical Trial
Official title:
Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.
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 deepen the efficacy of the functional ingredient blend in term of prebiotic effect,
gastrointestinal tolerance and immune response improvement.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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