Impact of a Fermented Infant Formula in Weaning Babies

Not Applicable

Completed

• Conditions: Weaning
• Interventions: Other: Fermented milk; Other: Standard milk; Other: Breastmilk

• Registration Number: NCT00858026
• Lead Sponsor: Bledina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-11
• Study Completion: 2008-06
• Status Verified: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-06
• Last Update Submitted: 2009-03-06
• Study First Posted: 2009-03-09
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• 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

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Exclusion Criteria

• 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 having received antibiotic therapy within the 3 weeks before the inclusion visit
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Fermented milk	Weaning with the fermented milk
2	Standard milk	Weaning with the standard milk
1	Breastmilk	Breastfed babies

Primary Outcome Measures

Name	Time	Method
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies	2, 3 and 5 months of age

Secondary Outcome Measures

Name	Time	Method
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 intestinal flora according to the nutrition group	3 and 5 months of age
Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group	9 months of age
Describe the infection signs according to the nutrition group	3 and 5 months of age
Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding	5 months of age

Trial Locations

Locations (3)

Cabinet médical; 🇫🇷 Roncq, France

Cabinet medical; 🇫🇷 Lambersart, France

Hôpital saint Vincent de Paul; 🇫🇷 Lille, France