Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)

March 17, 2015 updated by: Heinz Italia SpA

Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.

Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.

Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.

However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.

Study Type

Interventional

Enrollment (Actual)

360

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
      • Cernusco sul Naviglio (Milan), Italy, 20063
        • "Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia
      • Erba (Como), Italy, 22036
        • Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia
      • Melzo (MI), Italy, 20066
        • Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia
      • Milan, Italy, 20142
        • Azienda ospedaliera "San Paolo", Dipartimento di Pediatria
      • Milan, Italy, 20152
        • Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria
      • Milan, Italy, 20157
        • Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria
      • Piacenza, Italy, 29100
        • Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria

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

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy infants of both sexes, born at term with natural labor or cesarean birth
  2. Single birth
  3. Infant born between 37th - 42th gestation week (included)
  4. Infant with birth weight ≥ 2500 g
  5. APGAR score after 5 minutes of life > 7
  6. Infant born from parents of Caucasian race
  7. Exclusive breast feeding or formula feeding within 15 days from birth.
  8. Consensus form signed by both parents or by the legal tutor properly informed of the study.
  9. Parents able to understand the protocol requirements and to fill out the infants Diary.

Exclusion Criteria:

  1. Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
  2. Diseases jeopardizing intrauterine growth.
  3. Infant born from mother suffering from dismetabolic and/or chronic diseases.
  4. Unknown father
  5. Infant with parents who might not report at hospital controls or not follow the protocol.
  6. Infant already enrolled or selected for another clinical trial.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: group "S"
Breast milk
No Intervention: group "A"
Control Infant formula
Experimental: group "B"
Infant formula supplemented with 0.4 g/100 ml of oligosaccharides
Other: Infant formula (with GOS)
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
Time Frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.
Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.

Secondary Outcome Measures

Outcome Measure
Time Frame
The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.
Time Frame: Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.
Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.

Collaborators and Investigators

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

Sponsor

Heinz Italia SpA

Investigators

  • Principal Investigator: Carlo Agostoni, Prof, Azienda Ospedaliera San Paolo
  • Principal Investigator: Gian Vincenzo Zuccotti, Prof, Azienda Ospedaliera "Luigi Sacco"
  • Principal Investigator: Giacomo Biasucci, Dr, Ospedale Civile "G. da Saliceto"
  • Principal Investigator: Fabio Alberto Podestà, Dr, Ospedale San Carlo Borromeo
  • Principal Investigator: Amilcare Rottoli, Dr, "Casa Pia Ospitaliera Uboldo" - Ospedale "Santa Maria delle Stelle"
  • Principal Investigator: Cino Galluzzo, Dr, Ospedale "Sacra Famiglia del Fatebenefratelli"

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

February 1, 2006

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 12, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLA-1-GOS-05

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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