Growth of Infants Fed New Starter Formula

Nestlé

Status: Completed

Conditions: Dietary Intervention

Treatments: Other: control standard formula; Other: test starter infant formula; Other: test starter infant formula with synbiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079208

09.04.INF

Details and patient eligibility

About

The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.

Full description

Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.

The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.

Enrollment: 297 estimated patients

Sex: All

Ages: 11 days to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy newborn infant
• Full-term (> 37 weeks gestation)
• Birth weight > 2500 and < 4500 g
• 14±3 days of age on enrollment
• Singleton birth
• Infant's mother has elected not to breastfeed prior to enrollment
• Has not received solid foods
• Having obtained his/her legal representative's informed consent

Exclusion criteria

• Known or suspected cow-milk allergy
• Congenital illness or malformation that may affect infant feeding and/or growth
• Significant prenatal and/or postnatal disease
• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
• Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
• Has received oral or intravenous antibiotic therapy in the last 7 days
• Has received probiotics in the last 7 days
• Currently participating in another clinical study
• Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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297 participants in 3 patient groups, including a placebo group

standard starter infant formula

Placebo Comparator group

Description:

standard starter infant formula

Treatment:

Other: control standard formula

test starter formula

Experimental group

Description:

test infant formula

Treatment:

Other: test starter infant formula

test starter formula with synbiotics

Experimental group

Description:

starter formula with synbiotics and adapted protein levels

Treatment:

Other: test starter infant formula with synbiotics