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

February 2, 2015 updated by: Heinz Italia SpA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STUDY GROUP

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

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

What is the study measuring?

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
Time Frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.
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
Time Frame: At enrolment, after 60 and 135 days of life
Quantification of salivary IgA
At enrolment, after 60 and 135 days of life
Prebiotic effect
Time Frame: At enrolment and after 135 days of life
Microbiological analysis of feces
At enrolment and after 135 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinz Italia SpA

Collaborators

IRCCS Policlinico S. Matteo
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
Advanced Analytical Technologies

Investigators

  • Principal Investigator: Mauro Stronati, Prof., Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLA-LENI-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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