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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00486148
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Heinz Italia SpA

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Nutritional Safety Other: Infant formula (with GOS) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 15 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486148


Locations
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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
Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria
Milan, Italy, 20152
Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria
Milan, Italy, 20157
Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria
Piacenza, Italy, 29100
Sponsors and Collaborators
Heinz Italia SpA
Investigators
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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
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Publications:

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Responsible Party: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT00486148    
Other Study ID Numbers: PLA-1-GOS-05
First Posted: June 13, 2007    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by Heinz Italia SpA:
Formula
Feeding
Healthy
 Full
Term
Infants