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

NCT00486148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

  • Nutritional Safety

Interventions

OTHER

Infant formula (with GOS)

Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

Sponsors & Collaborators

  • Heinz Italia SpA

    lead INDUSTRY

Principal Investigators

  • Carlo Agostoni, Prof · Azienda Ospedaliera San Paolo

  • Gian Vincenzo Zuccotti, Prof · Azienda Ospedaliera "Luigi Sacco"

  • Giacomo Biasucci, Dr · Ospedale Civile "G. da Saliceto"

  • Fabio Alberto Podestà, Dr · Ospedale San Carlo Borromeo

  • Amilcare Rottoli, Dr · "Casa Pia Ospitaliera Uboldo" - Ospedale "Santa Maria delle Stelle"

  • Cino Galluzzo, Dr · Ospedale "Sacra Famiglia del Fatebenefratelli"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2011-10-31
Completion
2013-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486148 on ClinicalTrials.gov