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The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Extensively Hydrolyzed Formula | Experimental | Administered in context of oral food challenge and then for 16 weeks. |
|
| Comparator Formula | Active Comparator | Administered in context of oral food challenge and then for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Extensively Hydrolyzed Formula | Other |
| ||
| Active Comparator Formula |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Allergic Reaction | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | Anthropometric measurements of weight in all enrolled subjects. | 16 weeks |
| Growth | Anthropometric measurements of length/height in all enrolled subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy M Barber, PhD | Perrigo Nutritionals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Arkansas Children's Hosptial |
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| Other |
|
| 16 weeks |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Pediatric Care Medical Group | Huntington Beach | California | 92647 | United States |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
| Choc Psf, Amc | Orange | California | 92868 | United States |
| Allergy Medical Group of the North Area, INC | Roseville | California | 95678 | United States |
| Allergy & Asthma Medical Group and Research Center, APC | San Diego | California | 92123 | United States |
| 1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| Sneeze Wheeze and Itch Associates | Normal | Illinois | 61761 | United States |
| Institute for Allergy and Asthma | Chevy Chase | Maryland | 20815 | United States |
| Einstein Consulting Services, LLC & Virgo Carter Pediatrics | Silver Spring | Maryland | 20910 | United States |
| Clinical Research Institute | Plymouth | Minnesota | 55441 | United States |
| Clinical Research Solutions, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Allergy, Asthma, and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Carolina Ear Nose and Throat Clinic | Orangeburg | South Carolina | 29118 | United States |
| TTS Research | Boerne | Texas | 78006 | United States |
| STAAMP Clinical Research | San Antonio | Texas | 78251 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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