Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starter infant formula with pro and prebiotics | Active Comparator | starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age |
|
| starter infant formula without pro and prebiotics | Placebo Comparator | starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age |
|
| Breastfeeding group | No Intervention | exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| starter infant formula with pro and prebiotics | Other |
| ||
| Placebo comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Diarrhea and all infections with fever | Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year | over 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year | over 6 months and 1 year |
| Anthropometry | Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Michel Hascoet, Prof. | Maternité régionale de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse, Service de réanimation néonatale | Lyon | 69317 | France | |||
| Hôpital Arnaud de Villeneuve, Service de pédiatrie 2 |
Not provided
| ID | Term |
|---|---|
| D011392 | Proline |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| until 1 year |
| Digestive tolerance | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | until 1 year |
| Stool characteristics |
| at 3 and 6 months |
| Montpellier |
| 34295 |
| France |
| Maternité régionale de Nancy, Service de Néonatologie | Nancy | 54042 | France |
| Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin | Berlin | 13353 | Germany |
| Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin | Giessen | 35392 | Germany |
| Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin | Potsdam | 14467 | Germany |
| Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde | Amsterdam | 1007 MB | Netherlands |
| D004043 |
| Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |