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The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant starter formula | Active Comparator | standard infant formula |
|
| Infant starter formula + prebiotics + probiotics | Experimental | infant formula |
|
| Breastfeeding group | Other | reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Dietary Supplement |
| ||
| Breastfeeding |
| Measure | Description | Time Frame |
|---|---|---|
| stool bacterial populations | (Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in weight | weight | 3 months |
| Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hania Szajewska | The Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph | Marseille | 13008 | France | |||
| Hôpital de la Conception |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| D007774 | Lactation |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Other |
Breastfeeding |
|
| 3 months |
| changes in length | changes in length | 3 months |
| Marseille |
| 13015 |
| France |
| Hôpital Nord | Marseille | 13015 | France |
| The Medical University of Warsaw | Warsaw | 01-184 | Poland |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |