Status:
COMPLETED
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
Lead Sponsor:
Heinz Italia SpA
Collaborating Sponsors:
Fondazione IRCCS Policlinico San Matteo di Pavia
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
Conditions:
Formula Feeding of Healthy Full Term Infants
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointest...
Detailed Description
Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable. New-generation infant formulae contain functional ingredients able to m...
Eligibility Criteria
Inclusion
- Infants of both sexes born to natural or cesarean delivery
- Gestational age between 37 and 42 completed weeks
- Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
- Single birth
- Caucasian parents
- Infants being exclusively formula-fed by the 21st day of life
Exclusion
- Infants with genetic and/or congenital diseases
- Infants receiving antibiotic therapy
- Infants with neonatal diseases requiring hospitalisation for longer than 7 days
- Infants at risk for atopy and/or having familial history for atopy
- Mothers with metabolic or chronic diseases
- Infant selected for another clinical study
- Parents refusing to sign a written informed consent
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01197365
Start Date
August 1 2010
End Date
December 1 2014
Last Update
February 4 2015
Active Locations (1)
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1
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, Italy, 27100