Extensively Hydrolyzed Formula: Hypoallergenicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278446
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):

January 14, 2011
January 17, 2011
November 4, 2013
February 2011
June 2012   (Final data collection date for primary outcome measure)
Hypoallergenicity [ Time Frame: 14 Days ]
To demonstrate that the test formula does not provoke allergenic activity
Same as current
Complete list of historical versions of study NCT01278446 on Archive Site
Digestive Tolerance [ Time Frame: 1 Week ]
Same as current
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Extensively Hydrolyzed Formula: Hypoallergenicity
Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula
The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Food Hypersensitivity
  • Other: Extensively hydrolyzed, whey protein infant formula
    New hydrolyzed formula
    Other Name: Baby Formula
  • Other: Extensively hydrolyzed, casein protein infant formula
    Commercially available hydrolyzed infant formula
    Other Name: Baby Formula
  • Experimental: Test Formula
    New hydrolyzed whey formula
    Intervention: Other: Extensively hydrolyzed, whey protein infant formula
  • Active Comparator: Control Formula
    Commercially available hydrolyzed infant formula
    Intervention: Other: Extensively hydrolyzed, casein protein infant formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
August 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Not Provided
Study Director: Jose Saavedra, MD Nestle Nutrition
Principal Investigator: Anna Nowak-Wegrzyn, MD Mount Sinai Department of Pediatrics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP