Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
NCT ID: NCT01197365
Last Updated: 2015-02-04
Study Results
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Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2010-08-31
2014-12-31
Brief Summary
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Detailed Description
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New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.
The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.
The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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STUDY GROUP
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
Infant formula with GOS, beta-palmitate, acidified milk
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
CONTROL GROUP
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
Standard infant formula without functional ingredients
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
Interventions
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Infant formula with GOS, beta-palmitate, acidified milk
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
Standard infant formula without functional ingredients
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Days
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
UNKNOWN
Advanced Analytical Technologies
INDUSTRY
Heinz Italia SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Mauro Stronati, Prof.
Role: PRINCIPAL_INVESTIGATOR
FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
Locations
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Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, Italy
Countries
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References
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Fanaro S, Marten B, Bagna R, Vigi V, Fabris C, Pena-Quintana L, Arguelles F, Scholz-Ahrens KE, Sawatzki G, Zelenka R, Schrezenmeir J, de Vrese M, Bertino E. Galacto-oligosaccharides are bifidogenic and safe at weaning: a double-blind randomized multicenter study. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):82-8. doi: 10.1097/MPG.0b013e31817b6dd2.
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Other Identifiers
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PLA-LENI-09
Identifier Type: -
Identifier Source: org_study_id
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