NCT01880970

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 21, 2015

Status Verified

July 1, 2014

Enrollment Period

5 years

First QC Date

June 17, 2013

Last Update Submit

October 20, 2015

Conditions

Gastro-intestinal InfectionsInfections With Fever

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Morbidity

    over 6 months and 1 year

  • Anthropometry

    until 1 year

  • Digestive tolerance

    until 1 year

  • Stool characteristics

    at 3 and 6 months

Study Arms (3)

Starter infant formula with pro and prebiotics

ACTIVE 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

Other: starter infant formula with pro and prebiotics

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

Other: Placebo comparator

Breastfeeding group

NO INTERVENTION

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

Interventions

starter infant formula with pro and prebioticsOTHER
Starter infant formula with pro and prebiotics
Placebo comparatorOTHER
starter infant formula without pro and prebiotics

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
  • Significant pre-natal and/or post-natal diseases
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hôpital de la Croix Rousse, Service de réanimation néonatale

Lyon, 69317, France

Location

Hôpital Arnaud de Villeneuve, Service de pédiatrie 2

Montpellier, 34295, France

Location

Maternité régionale de Nancy, Service de Néonatologie

Nancy, 54042, France

Location

Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin

Berlin, 13353, Germany

Location

Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin

Giessen, 35392, Germany

Location

Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin

Potsdam, 14467, Germany

Location

Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde

Amsterdam, 1007 MB, Netherlands

Location

MeSH Terms

Interventions

ProlinePrebiotics

Intervention Hierarchy (Ancestors)

Imino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Jean Michel Hascoet, Prof.

    Maternité régionale de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

October 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 21, 2015

Record last verified: 2014-07

Locations

FR(3)DE(3)NL(1)