Dietary Intervention
Conditions
Keywords
infant formula, synbiotics, probiotics, nutrition
Brief summary
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.
Detailed 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.
Interventions
OTHERtest starter infant formula
infants are fed for 6 months with this starter formula
OTHERtest starter infant formula with synbiotics
infant are fed for 6 months with this formula
OTHERcontrol standard formula
infant are fed 6 months with this formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Days to 6 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance, morbidity, protein status, metabolic markers | 6 months |
Countries
United States
Outcome results
None listed