NCT00486148

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Heinz Italia SpA · Industry
• Sex: All
• Age: 1 Day – 15 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Nutritional Safety

Interventions

Type	Name	Description
OTHER	Infant formula (with GOS)	Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

Timeline

• Start date: 2006-02-01
• Primary completion: 2011-10-01
• Completion: 2013-06-01
• First posted: 2007-06-13
• Last updated: 2015-03-18

Locations

7 sites across 1 country: Italy