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| Name | Class |
|---|---|
| MAPI | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Breastfed babies |
|
| 2 | Active Comparator | Weaning with the standard milk |
|
| 3 | Experimental | Weaning with the fermented milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastmilk | Other | Exclusively breastfed babies |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Kalach, MD | Hopital Saint Vincent de Paul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet médical | Bondues | 59910 | France | |||
| Cabinet médical |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Standard milk | Other | Weaning babies fed with the standard formula |
|
|
| Fermented milk | Other | Weaning babies fed with the fermented formula |
|
|
| 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 |
| Dunkirk |
| 59240 |
| France |
| Cabinet medical | Lambersart | 59130 | France |
| Cabinet médical | Lille | 59000 | France |
| Hôpital saint Vincent de Paul | Lille | 59000 | France |
| Cabinet médical | Roncq | 59223 | France |
| D000074421 |
| Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |