Growth of Infants Fed New Starter Formula

Dietary Intervention Clinical Trial

Official title:

Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079208
• Other study ID #: 09.04.INF
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: December 2, 2014
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: October 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Intervention

Intervention

Other:
• test starter infant formula
infants are fed for 6 months with this starter formula
• test starter infant formula with synbiotics
infant are fed for 6 months with this formula
• control standard formula
infant are fed 6 months with this formula

Locations

Country	Name	City	State
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	Florida Institute for Clinical Research	Orlando	Florida
United States	UCSF Institute for Health Policy Studies/Pediatrics	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)		4 months	Yes
Secondary	Tolerance, morbidity, protein status, metabolic markers		6 months	Yes