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| ID | Type | Description | Link |
|---|---|---|---|
| MAGICO | Other Identifier | Ordesa |
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Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic
Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partially hydrolyzed formula (pHF) | Experimental | Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins. |
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| Standard formula (SF) | Active Comparator | Infants fed exclusively with a standard formula based on intact cow's milk proteins |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially hydrolyzed formula (pHF) | Dietary Supplement | Infant formula with partially hydrolyzed protein |
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| Measure | Description | Time Frame |
|---|---|---|
| Growth standard calculated z-scores | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) | From baseline to 3 months after starting with the formula |
| Symptoms associated with infant colic | Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter | From baseline to 3 months after starting with the formula |
| Measure | Description | Time Frame |
|---|---|---|
| Growth standard calculated z-scores | Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm) | At 6, 9 and 12 months old. |
| Gatrointestinal tolerance recording | Record in the patient's diary stool patterns (depositional rhythm and quality of faeces) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roser De Castellar, MD | Contact | +34 902105243 | Roser.DeCastellar@ordesa.es |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Martin Martínez | Consorci Sanitari de Terrassa | Principal Investigator |
| Gemma Colomé Rivero | Fundació Hospital de Nens de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari de Terrassa | Recruiting | Terrassa | Barcelona | 08227 | Spain |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Standard formula (SF) | Dietary Supplement | Infant formula with intact protein |
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| Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old |
| Infant illness and infection outcomes | Specific parent-reported infant symptoms (digestive, respiratory or other infections) | Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old |
| Behaviour/temperament test | Infant Behavior Questionnaire-Revised test: For this study, the very short form validated in Spanish that includes 37 items will be applied. Parents are asked to rate the frequency of specific, temperament-related behaviors observed during the last week. | 1, 6, 12 months old |
| Assessment of supplementary food | Investigator will collect data from the timetable for introduction of the different food groups | At 6 and 9 months old |
| Food survey at the first year of life | Investigator will conduct a food consumption frequency survey | At 12 months old |
| Product safety | Assessment of acceptance of the formula and record of potential adverse or side effects related to taking the product. | At 1, 2 and 3 months follow-up visit, and 6, 9 months old |
| Fundació Hospital de Nens | Active, not recruiting | Barcelona | 08009 | Spain |