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

NCT01197365 | Completed

• 1 other identifier: PLA-LENI-09
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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 gastrointestinal health and immune response in healthy term infants.

Conditions

Formula Feeding of Healthy Full Term Infants

Keywords

Acidified milk; Beta-palmitate; Bifidobacteria; Infant formula; Galacto-oligosaccharides; Growth; Infants; Prebiotics

Outcome Measures

Primary Outcomes (1)

• The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms

  Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.

  Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.

Secondary Outcomes (2)

• Immune-modulatory activity

  At enrolment, after 60 and 135 days of life

• Prebiotic effect

  At enrolment and after 135 days of life

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

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

CONTROL GROUP

OTHER

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

Interventions

Infant formula with GOS, beta-palmitate, acidified milk OTHER

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

STUDY GROUP

Standard infant formula without functional ingredients OTHER

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

CONTROL GROUP

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinz Italia SpA: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi): collaborator
• Advanced Analytical Technologies: collaborator

Study Sites (1)

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva

Pavia, PV, 27100, Italy

Location

Related Publications (26)

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• World Health Organization. Nutrient adequacy of exclusive breastfeeding for the term infant during the first six months of life. Geneva, 2002.

  BACKGROUND

• Civardi E, Garofoli F, Longo S, Mongini ME, Grenci B, Mazzucchelli I, Angelini M, Castellazzi A, Fasano F, Grinzato A, Fanos V, Budelli A, Stronati M. Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds. Clin Nutr. 2017 Feb;36(1):238-245. doi: 10.1016/j.clnu.2015.11.006. Epub 2015 Nov 27.

  PMID: 26718667 DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Mauro Stronati, Prof.

  FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IT (1)