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The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extensively hydrolyzed formula | Experimental | Feeding extensively hydrolyzed formula |
|
| Amino acid formula | Placebo Comparator | Feeding amino acid formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extensively Hydrolyzed formula | Dietary Supplement |
| ||
| Amino acid formula |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of infants tolerating the formula during a double blind placebo controlled food challenge | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Regurgitation assessed through Vandenplas score | 7, 45 and 90 days | |
| Vomiting (weekly frequency) | 7, 45 and 90 days | |
| Abdominal pain (severity on a 4 level scale) |
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Main Inclusion Criteria:
Infants:
Main Non-inclusion Criteria:
Infants:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Cucchiara | University Hospital Umberto I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umberto I university hospital | Roma | Italy |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Dietary Supplement |
|
| 7, 45 and 90 days |
| Bloating and gas (severity on a 4 level scale) | 7, 45 and 90 days |
| Stool consistency assessed through Bristol Stools Form Scale | 7, 45 and 90 days |
| Sleeping time over 24h | 7, 45 and 90 days |
| Stool frequency over 72h | 7, 45 and 90 days |
| Blood in stools (presence/absence) | 7, 45 and 90 days |
| Duration of crying over 24h | 7, 45 and 90 days |
| Respiratory symptoms (severity on a 4 level scale) | 7, 45 and 90 days |
| Urticaria (presence/absence) | 7, 45 and 90 days |
| Eczema assessed through SCORAD | 7, 45 and 90 days |
| Weight expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Height expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| BMI expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Head circumference expressed in z scores according to the WHO Child Growth Standards | 45 and 90 days |
| Number of patients with treatment emergent Adverse Events | 7, 45 and 90 days |