Growth of Infants Fed New Starter Formula

Completed · Not applicable

Conditions studied: Dietary Intervention

In brief

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.

Key facts

Study ID

NCT01079208

Run by

Société des Produits Nestlé (SPN)

People needed

297

Starts

2010-03-01

Expected to finish

2014-10-01

Last updated by the study team

2014-12-03

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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)

Where it is running

• UCSF Institute for Health Policy Studies/Pediatrics — San Francisco, California, United States
• Florida Institute for Clinical Research — Orlando, Florida, United States
• Midwest Children's Health Research Institute — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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