Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Test Formula
New hydrolyzed whey formula
Extensively hydrolyzed, whey protein infant formula
New hydrolyzed formula
Control Formula
Commercially available hydrolyzed infant formula
Extensively hydrolyzed, casein protein infant formula
Commercially available hydrolyzed infant formula
Interventions
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Extensively hydrolyzed, whey protein infant formula
New hydrolyzed formula
Extensively hydrolyzed, casein protein infant formula
Commercially available hydrolyzed infant formula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Two (2) months to ≤ 12 years of age at enrollment
3. Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
1. Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and \[detectable serum milk-specific IgE (\>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm\]), OR
2. Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
3. Results of laboratory tests highly predictive of clinical reactivity to milk
* Serum milk IgE ≥15 \[kIU/L\]or ≥ 5 \[kIU/L if younger than 1 year OR,
* Skin prick tests mean wheal \>10 mm
4. Otherwise healthy
5. If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
6. Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
7. Having obtained his/her legal representative's informed consent.
Exclusion Criteria
2. Any chromosomal or major congenital anomalies
3. Any major gastrointestinal disease or abnormalities other than CMA
4. Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
5. Immunodeficiency
6. Receiving free amino acid formula
7. Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
8. Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
9. Unstable asthma
10. Severe uncontrolled eczema
11. Recent ( within the last 3 months) severe anaphylactic reaction to milk
12. Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
13. Currently participating in another clinical trial
2 Months
12 Years
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jose Saavedra, MD
Role: STUDY_DIRECTOR
Nestle Nutrition
Anna Nowak-Wegrzyn, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Department of Pediatrics
Locations
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Little Rock Allergy & Asthma
Little Rock, Arkansas, United States
Pediatric Care Medical Group, Inc
Huntington Beach, California, United States
Allergy Medical Group of the North Area
Roseville, California, United States
Brookstone Clinical Research Center
Columbus, Georgia, United States
Aeroallergy Research Labs of Savannah
Savannah, Georgia, United States
Idaho Allergy and Asthma Specialists
Eagle, Idaho, United States
Deaconness Clinic
Evansville, Indiana, United States
Anderson & Collins Clinical Research
Edison, New Jersey, United States
Mount Sinai Faculty Practice Associates Pediatric Allergy
New York, New York, United States
ENT & Allergy Associates
Newburgh, New York, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
TTS Research
Boerne, Texas, United States
Clinical Research Partners
Henrico, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Countries
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Other Identifiers
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09.42.PED
Identifier Type: -
Identifier Source: org_study_id