Growth of Infants Fed New Starter Formula

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01079208
First received: March 2, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Dietary Intervention
Other: test starter infant formula
Other: test starter infant formula with synbiotics
Other: control standard formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance, morbidity, protein status, metabolic markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 297
Study Start Date: March 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: standard starter infant formula
standard starter infant formula
Other: control standard formula
infant are fed 6 months with this formula
Experimental: test starter formula
test infant formula
Other: test starter infant formula
infants are fed for 6 months with this starter formula
Experimental: test starter formula with synbiotics
starter formula with synbiotics and adapted protein levels
Other: test starter infant formula with synbiotics
infant are fed for 6 months with this formula

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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079208

Locations
United States, California
UCSF Institute for Health Policy Studies/Pediatrics
San Francisco, California, United States, 94118
United States, Florida
Florida Institute for Clinical Research
Orlando, Florida, United States, 32822
United States, Nebraska
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68504
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Michael Cabana, MD, MPH Institute for Health Policy Studies, University of California
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01079208     History of Changes
Other Study ID Numbers: 09.04.INF
Study First Received: March 2, 2010
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
infant formula, synbiotics, probiotics, nutrition

ClinicalTrials.gov processed this record on August 21, 2014