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

Kraft Heinz

Status: Completed

Conditions: Nutritional Safety

Treatments: Other: Infant formula (with GOS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486148

PLA-1-GOS-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 1 to 15 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups

group "S"

No Intervention group

Description:

Breast milk

group "A"

No Intervention group

Description:

Control Infant formula

group "B"

Experimental group

Description:

Infant formula supplemented with 0.4 g/100 ml of oligosaccharides

Treatment:

Other: Infant formula (with GOS)