Effect of Starter Formula on Infection Prevention

Not Applicable

Completed

• Conditions: Gastro-intestinal Infections; Infections With Fever
• Interventions: Other: starter infant formula with pro and prebiotics; Other: Placebo comparator

• Registration Number: NCT01880970
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-07
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starter infant formula with pro and prebiotics	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
starter infant formula without pro and prebiotics	Placebo comparator	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

Primary Outcome Measures

Name	Time	Method
Diarrhea and all infections with fever	over 6 months and 1 year	Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Morbidity	over 6 months and 1 year	Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year
Anthropometry	until 1 year	Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)
Digestive tolerance	until 1 year	Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Stool characteristics	at 3 and 6 months	* 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

Trial Locations

Locations (7)

Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde; 🇳🇱 Amsterdam, Netherlands

Hôpital Arnaud de Villeneuve, Service de pédiatrie 2; 🇫🇷 Montpellier, France

Hôpital de la Croix Rousse, Service de réanimation néonatale; 🇫🇷 Lyon, France

Maternité régionale de Nancy, Service de Néonatologie; 🇫🇷 Nancy, France

Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin; 🇩🇪 Giessen, Germany

Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin; 🇩🇪 Berlin, Germany

Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin; 🇩🇪 Potsdam, Germany