Growth of Infants Fed New Starter Formula

NCT01079208 | Completed

• 1 other identifier: 09.04.INF
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 3

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.

Conditions

Dietary Intervention

Keywords

infant formula, synbiotics, probiotics, nutrition

Outcome Measures

Primary Outcomes (1)

• Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)

  4 months

Secondary Outcomes (1)

• Tolerance, morbidity, protein status, metabolic markers

  6 months

Study Arms (3)

standard starter infant formula

PLACEBO COMPARATOR

standard starter infant formula

Other: control standard formula

test starter formula

EXPERIMENTAL

test infant formula

Other: test starter infant formula

test starter formula with synbiotics

EXPERIMENTAL

starter formula with synbiotics and adapted protein levels

Other: test starter infant formula with synbiotics

Interventions

test starter infant formula OTHER

infants are fed for 6 months with this starter formula

test starter formula

test starter infant formula with synbiotics OTHER

infant are fed for 6 months with this formula

test starter formula with synbiotics

control standard formula OTHER

infant are fed 6 months with this formula

standard starter infant formula

Eligibility Criteria

• Age: 11 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy newborn infant
• Full-term (\> 37 weeks gestation)
• Birth weight \> 2500 and \< 4500 g
• ±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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (3)

UCSF Institute for Health Policy Studies/Pediatrics

San Francisco, California, 94118, United States

Location

Florida Institute for Clinical Research

Orlando, Florida, 32822, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Michael Cabana, MD, MPH

  Institute for Health Policy Studies, University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2013-10

Locations

US (3)