An interventional study of Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients in Formula Feeding of Healthy Full Term Infants, sponsored by Heinz Italia SpA. Completed at 1 site in Italy. Open to participants aged Up to 21 Days. Per ClinicalTrials.gov, last updated 2015-02-04.
Sponsored by Heinz Italia SpA · Not applicable, Interventional, and Supportive care
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.
Heinz Italia SpA is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
Other: Infant formula with GOS, beta-palmitate, acidified milk
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
Other: Standard infant formula without functional ingredients
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.
Time frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.
Immune-modulatory activity
Quantification of salivary IgA
Time frame: At enrolment, after 60 and 135 days of life
Prebiotic effect
Microbiological analysis of feces
Time frame: At enrolment and after 135 days of life
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Heinz Italia SpA