Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Formula Feeding of Healthy Full Term Infants

Intervention / Treatment
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* Other: Infant formula with GOS, beta-palmitate, acidified milk
* Other: Standard infant formula without functional ingredients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STUDY GROUP<br>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<br>* 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<br>|
| Other: CONTROL GROUP<br>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<br>* Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune-modulatory activity | Quantification of salivary IgA | At enrolment, after 60 and 135 days of life | 
| Prebiotic effect | Microbiological analysis of feces | At enrolment and after 135 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acidified milk, Beta-palmitate, Bifidobacteria, Infant formula, Galacto-oligosaccharides, Growth, Infants, Prebiotics