Impact of a Fermented Infant Formula in Weaning Babies

Weaning Clinical Trial

Official title:

Impact of a Fermented Infant Formula in Weaning Babies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858026
• Other study ID #: BL009
• Status: Completed
• Phase: N/A
• First received: March 6, 2009
• Last updated: March 6, 2009
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2009
• Source: Bledina
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 54 Days to 68 Days

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Weaning

Intervention

Other:
• Breastmilk
Exclusively breastfed babies
• Standard milk
Weaning babies fed with the standard formula
• Fermented milk
Weaning babies fed with the fermented formula

Locations

Country	Name	City	State
France	Cabinet médical	Bondues
France	Cabinet médical	Dunkerque
France	Cabinet medical	Lambersart
France	Cabinet médical	Lille
France	Hôpital saint Vincent de Paul	Lille
France	Cabinet médical	Roncq

Sponsors (2)

Lead Sponsor	Collaborator
Bledina	MAPI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies		2, 3 and 5 months of age	No
Secondary	Describe the intestinal flora according to the nutrition group		3 and 5 months of age	No
Secondary	Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding		3 months of age	No
Secondary	Describe the growth, according to the nutrition group		3 and 5 months of age	No
Secondary	Describe the milk tolerance at the weaning according to the nutrition group		3 and 5 months of age	No
Secondary	Describe the infection signs according to the nutrition group		3 and 5 months of age	No
Secondary	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	No
Secondary	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	No