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| Name | Class |
|---|---|
| Biosearch S.A. | INDUSTRY |
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The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Damira/Celia peptide hydrolyzed casein | Experimental | Extensively Hydrolyzed (EH)casein infant formula |
|
| Picot riz/Celia rice/Sanutri arroz | Experimental | Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damira/Celia peptide hydrolyzed casein | Other |
| ||
| Picot riz/Celia rice/Sanutri arroz |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption. | Tolerance is absence of clinical signs. | 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement. | Evaluate during 3 months of consumption the effectiveness of the formulas, in terms of :
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of infant formula consumed by the infants | Volume of infant formula consumed by the infants in 3 months | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Children who have returned to breastfeeding
Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
In the past 15 days, treatment or medication likely to :
Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
Children who show signs of malnutrition, or prolonged diarrhea
Children whose parents show no willingness to comply with study requirements
Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biosearch S.A. | Granada | 18004 | Spain |
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| Other |
|
| ID | Term |
|---|---|
| D005183 | Failure to Thrive |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
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