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

N/ACompletedNCT01197365

Heinz Italia SpA148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

148

Conditions

Formula Feeding of Healthy Full Term Infants

Interventions

Infant formula with GOS, beta-palmitate, acidified milkOTHER

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 without functional ingredientsOTHER

Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Eligibility

Sex: ALLMax age: 21 Days

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Pavia, PV, Italy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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