Impact of a Fermented Infant Formula in Weaning Babies

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Fermented Infant Formula in Weaning Babies

Conditions
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Weaning

Intervention / Treatment
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* Other: Breastmilk
* Other: Standard milk
* Other: Fermented milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 54 Days
Maximum Age: 68 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Breastfed babies | Other: Breastmilk<br>* Exclusively breastfed babies<br>* Other names: No other names;|
| Active Comparator: 2<br>Weaning with the standard milk | Other: Standard milk<br>* Weaning babies fed with the standard formula<br>* Other names: No other names;|
| Experimental: 3<br>Weaning with the fermented milk | Other: Fermented milk<br>* Weaning babies fed with the fermented formula<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning, breastfeeding, infant formula, fermented formula