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Sponsored by: |
Nutricia North America |
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Information provided by: | Nutricia North America |
ClinicalTrials.gov Identifier: | NCT00664768 |
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA.
This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.
Condition | Intervention |
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Cow Milk Allergy |
Dietary Supplement: Neocate Infant Dietary Supplement: new Neocate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Blind Controlled Study to Evaluate the Nutritional Safety (Growth) and Hypoallergenicity of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies. |
Estimated Enrollment: | 109 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
New Neocate: Experimental
new Neocate
|
Dietary Supplement: new Neocate
minmum of 8 fl oz daily
|
Neocate Infant: Active Comparator |
Dietary Supplement: Neocate Infant
minimum of 8 fl. oz daily
|
Ages Eligible for Study: | up to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects aged from birth to 3 years old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
Written informed consent / ability to give informed consent.
Subjects aged from birth up to 8 months of age;
These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements, during the seven-day, post challenge feeding period and the Phase II growth assessment.
Subjects aged over 8 months to 3 years old
Exclusion Criteria:
All subjects
Infants whose parent/caregiver is younger than the legal age of consent
Subjects aged from birth up to 8 months of age;
United States, California | |
Choc Psf, Amc | Recruiting |
Orange, California, United States, 92868 | |
Contact: Elia Gonzales 714-633-6363 | |
United States, Georgia | |
Clinical Research Atlanta | Recruiting |
Stockbridge, Georgia, United States, 30281 | |
Contact: Susan Frank 770-507-6867 | |
United States, North Carolina | |
Duke University | Not yet recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Pamela Steele 919-732-2297 | |
United States, Pennsylvania | |
Childrens Hospital of Pittsburgh | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Elizabeth Hartigan 412-692-7885 | |
United States, Virginia | |
Huguenot Pediatrics | Recruiting |
Midlothian, Virginia, United States, 23113 | |
Contact: Tammy Creasy 804-794-2299 | |
Advanced Pediatrics | Recruiting |
Vienna, Virginia, United States, 22180 | |
Contact: Mary Margaret Thorne 703-938-5581 |
Responsible Party: | Nutricia North America ( Steven Yannicelli, PhD, RD ) |
Study ID Numbers: | CT0131 |
Study First Received: | April 21, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00664768 |
Health Authority: | United States: Institutional Review Board |
hypoallergenicity Cow Milk Allergy DBPCFC Stool micorflora Stool characteristics |
Food Hypersensitivity Hypersensitivity Milk Hypersensitivity Hypersensitivity, Immediate |
Immune System Diseases |