NCT00858026

Brief Summary

When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

6 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

April 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

1.6 years

First QC Date

March 6, 2009

Last Update Submit

March 6, 2009

Conditions

Weaning

Keywords

weaningbreastfeedinginfant formulafermented formula

Outcome Measures

Primary Outcomes (1)

  • To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies

    2, 3 and 5 months of age

Secondary Outcomes (7)

  • Describe the intestinal flora according to the nutrition group

    3 and 5 months of age

  • Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding

    3 months of age

  • Describe the growth, according to the nutrition group

    3 and 5 months of age

  • Describe the milk tolerance at the weaning according to the nutrition group

    3 and 5 months of age

  • Describe the infection signs according to the nutrition group

    3 and 5 months of age

  • +2 more secondary outcomes

Study Arms (3)

1

OTHER

Breastfed babies

Other: Breastmilk

2

ACTIVE COMPARATOR

Weaning with the standard milk

Other: Standard milk

3

EXPERIMENTAL

Weaning with the fermented milk

Other: Fermented milk

Interventions

BreastmilkOTHER

Exclusively breastfed babies

Also known as: No other names
1
Standard milkOTHER

Weaning babies fed with the standard formula

Also known as: No other names
2
Fermented milkOTHER

Weaning babies fed with the fermented formula

Also known as: No other names
3

Eligibility Criteria

Age54 Days - 68 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
  • Born at 37 weeks of amenorrhea or more
  • Exclusively breastfed since birth
  • Written informed consent given by both parents (or tutors) for study participation
  • Parents (or tutors) agreeing on the follow-up by one of the study investigators

You may not qualify if:

  • Infant with congenital or acquired immunodeficiency, whatever the aetiology
  • Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
  • Infant with congenital and/or chromosomal malformation,
  • infant receiving a treatment susceptible to interfere with the measure of study parameters
  • Antibiotic therapy per/pre/post partum \> 48 h
  • Infant needing the prescription of a specific milk (HA, without cow milk)
  • Infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cabinet médical

Bondues, 59910, France

Location

Cabinet médical

Dunkirk, 59240, France

Location

Cabinet medical

Lambersart, 59130, France

Location

Cabinet médical

Lille, 59000, France

Location

Hôpital saint Vincent de Paul

Lille, 59000, France

Location

Cabinet médical

Roncq, 59223, France

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Nicolas Kalach, MD

    Hopital Saint Vincent de Paul

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

June 1, 2008

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

FR(6)