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Extensively Hydrolyzed Formula: Hypoallergenicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01278446
First received: January 14, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Food Hypersensitivity
Other: Extensively hydrolyzed, whey protein infant formula
Other: Extensively hydrolyzed, casein protein infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Hypoallergenicity [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    To demonstrate that the test formula does not provoke allergenic activity


Secondary Outcome Measures:
  • Digestive Tolerance [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Formula
New hydrolyzed whey formula
Other: Extensively hydrolyzed, whey protein infant formula
New hydrolyzed formula
Other Name: Baby Formula
Active Comparator: Control Formula
Commercially available hydrolyzed infant formula
Other: Extensively hydrolyzed, casein protein infant formula
Commercially available hydrolyzed infant formula
Other Name: Baby Formula

  Eligibility

Ages Eligible for Study:   2 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278446

Locations
United States, Arkansas
Little Rock Allergy & Asthma
Little Rock, Arkansas, United States
United States, California
Pediatric Care Medical Group, Inc
Huntington Beach, California, United States
Allergy Medical Group of the North Area
Roseville, California, United States, 95678
United States, Georgia
Brookstone Clinical Research Center
Columbus, Georgia, United States
Aeroallergy Research Labs of Savannah
Savannah, Georgia, United States, 31406
United States, Idaho
Idaho Allergy and Asthma Specialists
Eagle, Idaho, United States, 83616
United States, Indiana
Deaconness Clinic
Evansville, Indiana, United States
United States, New Jersey
Anderson & Collins Clinical Research
Edison, New Jersey, United States
United States, New York
Mount Sinai Faculty Practice Associates Pediatric Allergy
New York, New York, United States, 10029
ENT & Allergy Associates
Newburgh, New York, United States
United States, North Carolina
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States, 28801
United States, Texas
TTS Research
Boerne, Texas, United States
United States, Virginia
Clinical Research Partners
Henrico, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Jose Saavedra, MD Nestle Nutrition
Principal Investigator: Anna Nowak-Wegrzyn, MD Mount Sinai Department of Pediatrics
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01278446     History of Changes
Other Study ID Numbers: 09.42.PED
Study First Received: January 14, 2011
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Cow's Milk Allergy
CMA

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014