Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)

Not Applicable

Completed

• Conditions: Nutritional Safety
• Interventions: Other: Infant formula (with GOS)

• Registration Number: NCT00486148
• Lead Sponsor: Heinz Italia SpA

Brief Summary

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.

Detailed Description

Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.

Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.

Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.

However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-13
• Primary Completion: 2011-10
• Study Completion: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Healthy infants of both sexes, born at term with natural labor or cesarean birth
2. Single birth
3. Infant born between 37th - 42th gestation week (included)
4. Infant with birth weight ≥ 2500 g
5. APGAR score after 5 minutes of life > 7
6. Infant born from parents of Caucasian race
7. Exclusive breast feeding or formula feeding within 15 days from birth.
8. Consensus form signed by both parents or by the legal tutor properly informed of the study.
9. Parents able to understand the protocol requirements and to fill out the infants Diary.

Exclusion Criteria

1. Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
2. Diseases jeopardizing intrauterine growth.
3. Infant born from mother suffering from dismetabolic and/or chronic diseases.
4. Unknown father
5. Infant with parents who might not report at hospital controls or not follow the protocol.
6. Infant already enrolled or selected for another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group "B"	Infant formula (with GOS)	Infant formula supplemented with 0.4 g/100 ml of oligosaccharides

Primary Outcome Measures

Name	Time	Method
The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.	Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.

Secondary Outcome Measures

Name	Time	Method
The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.	Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.

Trial Locations

Locations (7)

"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia; 🇮🇹 Cernusco sul Naviglio (Milan), Italy

Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia; 🇮🇹 Melzo (MI), Italy

Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia; 🇮🇹 Erba (Como), Italy

Azienda ospedaliera "San Paolo", Dipartimento di Pediatria; 🇮🇹 Milan, Italy

Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria; 🇮🇹 Milan, Italy

Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria; 🇮🇹 Milan, Italy

Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria; 🇮🇹 Piacenza, Italy