Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants

Société des Produits Nestlé (SPN)7 sites in 3 countries477 target enrollmentOctober 2008

Overview

The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

October 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

•Healthy newborn infant
•Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
•Age of infant is ≤ 13 days at the time of enrollment
•Birth weight ≥ 2500g and ≤ 4500g
•For the FF groups: The infant's mother has elected not to breastfeed
•For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
•Having obtained his/her legal representative's informed consent

•Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
•Significant pre-natal and/or post-natal diseases
•Perinatal antibiotic or infants on antibiotics at the time of inclusion
•Infants whose mother has had an acute infection during the last month of pregnancy
•Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study)
•Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
•Newborn whose parents / caregivers cannot be expected to comply with treatment
•Newborn currently participating in another interventional clinical trial