NCT03090360

Growth of Infants Fed a New Term Infant Formula

Growth of Infants Fed a New Term Infant Formula With a Prebiotic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

Summary

To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Detailed description

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant formula (CF)	Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
DIETARY_SUPPLEMENT	Infant Formula (EF)	Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.

Timeline

• Start date: 2017-02-21
• Primary completion: 2019-04-11
• Completion: 2019-05-21
• First posted: 2017-03-24
• Last updated: 2019-07-05

Locations

7 sites across 2 countries: Belgium, Italy