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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Heinz Italia SpA.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Heinz Italia SpA
ClinicalTrials.gov Identifier:
NCT00486148
First received: June 12, 2007
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Nutritional Safety
Other: Infant formula (with GOS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants

Resource links provided by NLM:


Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2006
Estimated Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 15 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486148

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

Publications:

Responsible Party: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT00486148     History of Changes
Other Study ID Numbers: PLA-1-GOS-05
Study First Received: June 12, 2007
Last Updated: April 5, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:
Formula
Feeding
Healthy
Full
Term
Infants

ClinicalTrials.gov processed this record on August 28, 2014