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Completed

NCT Number: NCT00858026

Impact of a Fermented Infant Formula in Weaning Babies

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.

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Key information

Conditions

Weaning Behavior Breast Feeding Feeding Behavior

Age range

54 day–68 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet médical, Bondues, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breastmilk

Other

Exclusively breastfed babies

Other names: No other names

Standard milk

Other

Weaning babies fed with the standard formula

Other names: No other names

Fermented milk

Other

Weaning babies fed with the fermented formula

Other names: No other names

Primary outcomes

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

    Time frame: 2, 3 and 5 months of age

Secondary outcomes

  1. Describe the intestinal flora according to the nutrition group

    Time frame: 3 and 5 months of age

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

    Time frame: 3 months of age

  3. Describe the growth, according to the nutrition group

    Time frame: 3 and 5 months of age

  4. Describe the milk tolerance at the weaning according to the nutrition group

    Time frame: 3 and 5 months of age

  5. Describe the infection signs according to the nutrition group

    Time frame: 3 and 5 months of age

  6. Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group

    Time frame: 9 months of age

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

    Time frame: 5 months of age

Sponsors and collaborators

Lead sponsor

Bledina

Industry

Collaborators

  • MAPI

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Mar 9, 2009
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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