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Effect of Starter Formula on Infection Prevention

Primary Purpose

Gastro-intestinal Infections, Infections With Fever

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
starter infant formula with pro and prebiotics
Placebo comparator
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastro-intestinal Infections

Eligibility Criteria

undefined - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital de la Croix Rousse, Service de réanimation néonatale
  • Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
  • Maternité régionale de Nancy, Service de Néonatologie
  • Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
  • Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
  • Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
  • Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Starter infant formula with pro and prebiotics

starter infant formula without pro and prebiotics

Breastfeeding group

Arm Description

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 from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2013
Last Updated
October 20, 2015
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01880970
Brief Title
Effect of Starter Formula on Infection Prevention
Official Title
Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-intestinal Infections, Infections With Fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starter infant formula with pro and prebiotics
Arm Type
Active Comparator
Arm Description
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
Arm Title
starter infant formula without pro and prebiotics
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Breastfeeding group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
starter infant formula with pro and prebiotics
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Primary Outcome Measure Information:
Title
Diarrhea and all infections with fever
Description
Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year
Time Frame
over 6 months and 1 year
Secondary Outcome Measure Information:
Title
Morbidity
Description
Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year
Time Frame
over 6 months and 1 year
Title
Anthropometry
Description
Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)
Time Frame
until 1 year
Title
Digestive tolerance
Description
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time Frame
until 1 year
Title
Stool characteristics
Description
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
Time Frame
at 3 and 6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Michel Hascoet, Prof.
Organizational Affiliation
Maternité régionale de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse, Service de réanimation néonatale
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Maternité régionale de Nancy, Service de Néonatologie
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands

12. IPD Sharing Statement

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Effect of Starter Formula on Infection Prevention

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