Clinical trial NCT01079208: Growth of Infants Fed New Starter Formula
Official title: Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Intervention
Keywords: infant formula, synbiotics, probiotics, nutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 297
Sex: ALL
Minimum age (years): 11
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)
timeFrame: 4 months
Secondary outcomes:
measure: Tolerance, morbidity, protein status, metabolic markers
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Institute for Health Policy Studies/Pediatrics
state: California
city: Orlando
country: United States
facility: Florida Institute for Clinical Research
state: Florida
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
Study officials:
affiliation: Institute for Health Policy Studies, University of California
name: Michael Cabana, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: