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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Heinz Italia SpA
Sponsor:
Collaborators:
Fondazione IRCCS Policlinico San Matteo - Struttura Complessa di Neonatologia, Patologia Neonatale e Terapia Intensiva (Prof. Mauro Stronati)
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
AAT (Advanced Analytical Technologies) (Dr. Elena Bessi/Sara Soldi)
Information provided by (Responsible Party):
Heinz Italia SpA
ClinicalTrials.gov Identifier:
NCT01197365
First received: September 7, 2010
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Formula Feeding of Healthy Full Term Infants
Other: Infant formula with GOS, beta-palmitate, acidified milk
Other: Standard infant formula without functional ingredients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.


Secondary Outcome Measures:
  • Immune-modulatory activity [ Time Frame: At enrolment, after 60 and 135 days of life ] [ Designated as safety issue: No ]
    Quantification of salivary IgA

  • Prebiotic effect [ Time Frame: At enrolment and after 135 days of life ] [ Designated as safety issue: No ]
    Microbiological analysis of feces


Estimated Enrollment: 136
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

CONTROL GROUP
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
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

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 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.

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197365

Contacts
Contact: Andrea Budelli 0039 02 52563332 andrea.budelli@it.hjheinz.com

Locations
Italy
Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva Recruiting
Pavia, PV, Italy, 27100
Sponsors and Collaborators
Heinz Italia SpA
Fondazione IRCCS Policlinico San Matteo - Struttura Complessa di Neonatologia, Patologia Neonatale e Terapia Intensiva (Prof. Mauro Stronati)
Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi)
AAT (Advanced Analytical Technologies) (Dr. Elena Bessi/Sara Soldi)
Investigators
Principal Investigator: Mauro Stronati, Prof. FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA
  More Information

Publications:

Responsible Party: Heinz Italia SpA
ClinicalTrials.gov Identifier: NCT01197365     History of Changes
Other Study ID Numbers: PLA-LENI-09
Study First Received: September 7, 2010
Last Updated: August 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:
Acidified milk
Beta-palmitate
Bifidobacteria
Infant formula
Galacto-oligosaccharides
Growth
Infants
Prebiotics

ClinicalTrials.gov processed this record on October 23, 2014