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| Name | Class |
|---|---|
| Keyrus Biopharma | OTHER |
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The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic, following nutritional management of these disorders by a preparation for thickened infants, reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of life is assessed using the QUALIN questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regurgitation | 45 infants aged 0 to 5 months suffering from regurgitation |
| |
| colic | 45 infants aged 0 to 5 months suffering from colic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Management of Infant Digestive Disorders and Quality of Life | Other | The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life in infants with regurgitation and colic | The main endpoint will be an increase in the QUALIN (QUALIté de vie du Nourrison) score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only. This score is between -68 to +68. An increase in score means an improvement in symptoms. | 4 months |
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Inclusion Criteria:
Full-term infants (> 37 weeks gestation and <42 weeks gestation), less than 4 months of age at recruitment
Exclusion Criteria:
Infant born prematurely (<37 weeks)
• Intercurrent pathology other than a functional intestinal disorder which can by themselves cause, directly or as a result of treatments, a functional intestinal disorder: Study Management of infant digestive disorders and Quality of life
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infants between 0 and 5 months
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandra Brancato | Brignon | 30190 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37305080 | Derived | Chouraqui JP, Brancato S, Delmas B, Hanh T. Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic. Front Nutr. 2023 May 25;10:1164722. doi: 10.3389/fnut.2023.1164722. eCollection 2023. |
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| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D005764 | Gastroesophageal Reflux |
| D003085 | Colic |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004778 |
| Environment and Public Health |