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Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

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ClinicalTrials.gov Identifier: NCT01197365
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : February 4, 2015
Sponsor:
Collaborators:
IRCCS Policlinico S. Matteo
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
Advanced Analytical Technologies
Information provided by (Responsible Party):
Heinz Italia SpA

September 7, 2010
September 9, 2010
February 4, 2015
August 2010
March 2014   (Final data collection date for primary outcome measure)
The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms [ Time Frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary. ]
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.
Same as current
Complete list of historical versions of study NCT01197365 on ClinicalTrials.gov Archive Site
  • Immune-modulatory activity [ Time Frame: At enrolment, after 60 and 135 days of life ]
    Quantification of salivary IgA
  • Prebiotic effect [ Time Frame: At enrolment and after 135 days of life ]
    Microbiological analysis of feces
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
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 gastrointestinal health and immune response in healthy term infants.

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 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Formula Feeding of Healthy Full Term Infants
  • Other: 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

  • Other: 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
  • Experimental: 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

    Intervention: Other: Infant formula with GOS, beta-palmitate, acidified milk
  • CONTROL GROUP
    Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
    Intervention: Other: Standard infant formula without functional ingredients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
136
December 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
up to 21 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01197365
PLA-LENI-09
No
Not Provided
Not Provided
Heinz Italia SpA
Heinz Italia SpA
  • IRCCS Policlinico S. Matteo
  • Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
  • Advanced Analytical Technologies
Principal Investigator: Mauro Stronati, Prof. FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
Heinz Italia SpA
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP