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The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant formula | Active Comparator | HA formula + starch + L. reuteri |
|
| Standard Formula | Placebo Comparator | Standard Infant Formula |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HA formula + starch + L. reuteri | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regurgitation | The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups. | four weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | To assess whether the groups have comparable growth | Four weeks of treatment |
| Regurgitation score | To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavia Indrio, MD | University of Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Pediatrico Giovanni XXIII | Bari | BA | 70100 | Italy |
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| ID | Term |
|---|---|
| D057045 | Laryngopharyngeal Reflux |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Four weeks treatment |
| Gastric empty rate | To compare the ultrasound gastric empty rate | Four week treatment |
| Digestive tolerance | To assess the infants' digestive tolerance | Four weeks treatment |
| Stool frequency | To assess stool frequency | Four weeks treatment |
| compliance | To assess the subject's compliance to product consumption. | four weeks intervention |
| Financial and non-financial burden | To measure family financial and non-financial burden related with the regurgitation | Four week treatment |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |