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

Kraft Heinz

Status: Completed

Conditions: Formula Feeding of Healthy Full Term Infants

Treatments: Other: Infant formula with GOS, beta-palmitate, acidified milk; Other: Standard infant formula without functional ingredients

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01197365

PLA-LENI-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 2 patient groups

STUDY GROUP

Experimental group

Description:

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

Treatment:

Other: Infant formula with GOS, beta-palmitate, acidified milk

CONTROL GROUP

Other group

Description:

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

Treatment:

Other: Standard infant formula without functional ingredients