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The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New thickened infant formula | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New thickened formula | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of regurgitation per day | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Regurgitation score | 14 days | |
| Regurgitation score | 3 months | |
| Digestive tolerance (stools' number and consistency) |
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Inclusion Criteria:
Infants :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvan Vandenplas, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatricians | Belgium | Belgium | ||||
| Universitair Ziekenhuis |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Digestive tolerance of the formula assessed through stools' number and consistency |
| 14 days |
| Digestive tolerance (stools' number and consistency) | Digestive tolerance of the formula assessed through stools' number and consistency | 3 months |
| Growth parameters (Weight, height and head circumference) | Weight, height and head circumference | 3 months |
| Brussels |
| 1090 |
| Belgium |
| Pediatricians | France | France |
| D004066 | Digestive System Diseases |