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| Name | Class |
|---|---|
| Statitec | INDUSTRY |
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The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).
The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | new thickened infant formula containing fibres |
|
| Control | Active Comparator | infant formula thickened with locust bean |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant formula | Other | Exclusive formula feeding with the new infant formula thickened with fibers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of regurgitation | Decrease of the daily number of regurgitation between baseline and day 14 | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of regurgitations | Change in the daily number of regurgitation between baseline and day 30 / day 90 | Day 30, Day 90 |
| Severity of regurgitation episodes | Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magalie JEGAT | Contact | +330155372222 | m.jegat@novalac.com | |
| ANNE-SOPHIE GARREAU | Contact | as.garreau@novalac.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center_14 | Active, not recruiting | Namur | Belgium | |||
| Center_15 |
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| Infant formula thickened with locust bean gum | Other | Exclusive formula feeding with the formula thickened with locust bean |
|
| Day 14, Day 30, Day 90 |
| Stools' frequency | Average daily stool's number | Day 14, Day 30, Day 90 |
| Stools' consistency | The Amsterdam Infant Stool Scale (AISS) (consistency categories: A [watery] to D [hard]; higher categories indicate firmer stools) | Day 14, Day 30, Day 90 |
| Frequency of diarrhea | Frequency : Occurence of diarrhea | Day 14, Day 30, Day 90 |
| Severity of diarrhea | Severity of diarrhea assessed using a study-specific score calculated as the sum of the products of each watery stool and its volume over 2 days (minimum score: 6; no upper limit; higher scores indicate more severe diarrhea) | Day 14, Day 30, Day 90 |
| Frequency of constipation | Occurence of constipation | Day 14, Day 30, Day 90 |
| Severity of constipation | Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation) | Day 14, Day 30, Day 90 |
| Crying time | Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more) | Day 14, Day 30, Day 90 |
| Feeding refusal | Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always) | Day 14, Day 30, Day 90 |
| Abnormal posturing | Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always) | Day 14, Day 30, Day 90 |
| Sleep quality | Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor) | Day 14, Day 30, Day 90 |
| Anthropometric parameters - Weight | Body weight measured in kilograms (kg) | Day 14, Day 30, Day 90 |
| Anthropometric parameters - Length | Body length measured in centimeters (cm) | Day 14, Day 30, Day 90 |
| Anthropometric parameters - Head circumference | Head circumference measured in centimeters (cm) | Day 14, Day 30, Day 90 |
| Anthropometric parameters - BMI | Body mass index calculated as kg/m² | Day 14, Day 30, Day 90 |
| Anthropometric parameters - Weight-for-height z-score | Weight-for-height z-score calculated according to WHO Child Growth Standards | Day 14, Day 30, Day 90 |
| Use of drug treatments | Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment | Day 14, Day 30, Day 90 |
| Parents' satisfaction | Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion) | Day 14, Day 30, Day 90 |
| Investigator's satisfaction | Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion) | Day 14, Day 30, Day 90 |
| Recruiting |
| Thuin |
| Belgium |
|
| Center_09 | Active, not recruiting | Castelnau-le-Lez | France |
| Center_02 | Recruiting | Étampes | France |
|
| Center_05 | Recruiting | Libourne | France |
|
| Centre_10 | Recruiting | Maromme | France |
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| Center_16 | Recruiting | Nice | France |
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| Center_08 | Recruiting | Vincennes | France |
|
| Center_01 | Recruiting | Athens | Greece |
|
| Center_11 | Recruiting | Thessaloniki | Greece |
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| Center_12 | Recruiting | Naples | Italy |
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| Center_13 | Recruiting | Naples | Italy |
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C017471 | locust bean gum |
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