Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
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 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|
- 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 ]
- 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 ]
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||May 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
No Intervention: group "S"
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
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.
|"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|
|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"|