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A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).
The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A: Mg alginate/thickened formula |
|
| Group B | Active Comparator | Group B: thickened formula/Mg alginate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thickened formula | Dietary Supplement |
| ||
| Mg alginate |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of symptom scores | Infant Gastroesophageal Reflux Questionnaire Revised | From day 0 to day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital | Bari | 70124 | Italy |
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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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| Dietary Supplement |
|
| reassurance with lifestyle changes | Behavioral |
|
| D004066 | Digestive System Diseases |