Effect of Starter Formula on Infection Prevention

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

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

Study Overview

• Status: Completed
• Conditions: Gastro-intestinal Infections; Infections With Fever
• Intervention / Treatment: Other: starter infant formula with pro and prebiotics; Other: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69317
    • Hôpital de la Croix Rousse, Service de réanimation néonatale
  • Montpellier, France, 34295
    • Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
  • Nancy, France, 54042
    • Maternité régionale de Nancy, Service de Néonatologie
• Germany
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
  • Giessen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
  • Potsdam, Germany, 14467
    • Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Starter infant formula with pro and prebiotics; starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age	Other: starter infant formula with pro and prebiotics
PLACEBO_COMPARATOR: starter infant formula without pro and prebiotics; starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age	Other: Placebo comparator
NO_INTERVENTION: Breastfeeding group; exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea and all infections with fever	Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year	over 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year	over 6 months and 1 year
Anthropometry	Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)	until 1 year
Digestive tolerance	Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)	until 1 year
Stool characteristics	Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis); Stool pH; Stool and saliva S.IgA; Stool Alpha 1-antitrypsine as infection/inflammation marker	at 3 and 6 months

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Jean Michel Hascoet, Prof., Maternité régionale de Nancy

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (ESTIMATE): June 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Temperature Changes; Infections; Communicable Diseases; Fever
• Other Study ID Numbers: 07.20.INF