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This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
The primary objective of the study is to evaluate the cumulative incidence of atopic dermatitis in healthy infants at risk for dysbiosis at 12 months of age and to identify factors associated with the presence of atopic dermatitis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Other | Healthy full-term infants fed on an infant formula marketed on the French market |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of atopic dermatitis in the infants included in the study | Number of episodes of dermatitis reported during the 12 months of follow-up, and objectified by a SCORAD score > 0. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Atopic dermatitis | Cumulative incidence of episodes of moderate atopic dermatitis (SCORAD score of 25 to 50) or severe episodes (SCORAD score> 50) | 3, 6 and 12 months |
| Gastrointestinal tolerance |
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Inclusion Criteria:
full-term infant (gestational age ≥ 37 and ≤ 42 weeks) in good health;
Having at least one risk factor for dysbiosis, including:
Aged at most 5 weeks;
Having a weight in the reference values for gestational age and sex (between the 10th and the 90th percentiles according to the growth curves in force);
Already consuming an infant formula (with or without associated breast milk), or whose mother wishes to introduce an infant formula at the end of this consultation to switch to mixed breastfeeding or to start weaning;
Authorization of a parent (or both) or legal representative of the child to collect personal information about their child and family.
Exclusion Criteria:
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Infants up to 1 month + 1 week, in good health, at risk of dysbiosis
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| Name | Affiliation | Role |
|---|---|---|
| Florence MD CAMPEOTTO | Scientific Committee | Study Chair |
| Hugues MD PILOQUET | Scientific Committee | Study Chair |
| Alexis MD MOSCA | Scientific Committee | Study Chair |
| Olivier MD GOULET | Scientific Committee | Study Chair |
| Marie-José MD BUTEL | Scientific Committee | Study Chair |
| Anne-Judith MD WALIGORA | Scientific Committee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Office | Taverny | France |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 3, 6 and 12 months |
| Height | Growth in term of height | 3, 6 and 12 months |
| Weight | Growth in term of weight | 3, 6 and 12 months |
| Cranial perimeter | Growth in terme of cranial perimeter | 3, 6 and 12 months |
| Observance | % of children who consumed the formula prescribed by the doctor at the previous visit | 3, 6 and 12 months |
| Consumption | Number of days of consumption during the previous period. | 3, 6 and 12 months |
| Satisfaction with Likert scale | 5-level Likert scale filled in by the doctor and by parents | 3, 6 and 12 months |
| Cumulative incidence of allergic manifestations | Cumulative number since the inclusion of episodes of:
| 3, 6 and 12 months |
| Cumulative incidence of infections | Cumulative number since the inclusion of episodes of:
| 3, 6 and 12 months |
| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |