Clinical trial NCT01278446: Extensively Hydrolyzed Formula: Hypoallergenicity
Official title: Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Keywords: Cow's Milk Allergy
CMA
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-01-17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.


Eligibility criteria: Inclusion Criteria:

1. Born at term (\>36 weeks gestation)
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:

1. Children consuming mother's milk at the time of inclusion and during the trial
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

Primary outcomes:
measure: Hypoallergenicity
timeFrame: 14 Days
Secondary outcomes:
measure: Digestive Tolerance
timeFrame: 1 Week
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma
state: Arkansas
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc
state: California
city: Roseville
country: United States
facility: Allergy Medical Group of the North Area
state: California
city: Columbus
country: United States
facility: Brookstone Clinical Research Center
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Labs of Savannah
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy and Asthma Specialists
state: Idaho
city: Evansville
country: United States
facility: Deaconness Clinic
state: Indiana
city: Edison
country: United States
facility: Anderson & Collins Clinical Research
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Faculty Practice Associates Pediatric Allergy
state: New York
city: Newburgh
country: United States
facility: ENT & Allergy Associates
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Henrico
country: United States
facility: Clinical Research Partners
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Nestle Nutrition
name: Jose Saavedra, MD
role: STUDY_DIRECTOR
affiliation: Mount Sinai Department of Pediatrics
name: Anna Nowak-Wegrzyn, MD
role: PRINCIPAL_INVESTIGATOR
References: