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Elemental Formula Hypoallergenicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01569776
First received: March 30, 2012
Last updated: June 24, 2013
Last verified: June 2013
History of Changes
  Purpose
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Condition Intervention
Food Hypersensitivity
 Other: Amino Acid formula
Other: Commercially available Amino Acid 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 an Amino Acid-Based Infant Formula

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • occurrence of allergic reactions [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)


Secondary Outcome Measures:
  • Digestive Tolerance [ Time Frame: one week ] [ Designated as safety issue: No ]
    gastrointestinal tolerance and formula intake recorded during the open challenge phase.
Enrollment: 37
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Amino Acid formula Other: Amino Acid formula
Amino Acid baby formula
Active Comparator: Control formula
Commercially available Amino Acid infant formula
 Other: Commercially available Amino Acid Formula
Hypoallergenic Baby formula

  Eligibility
Ages Eligible for Study:   2 Months to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born at term (>36 weeks gestation)
  • 2 months to ≤12 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
  • Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
  • Having obtained his/her legal representative's informed consent

Exclusion:

  • Children consuming mother's milk at the time of inclusion and during the trial
  • Any chromosomal or major congenital anomalies
  • Any major gastrointestinal disease or abnormalities other than CMA
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
  • Immunodeficiency
  • Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
  • Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
  • Unstable asthma
  • Severe uncontrolled eczema
  • Severe anaphylactic reaction to milk within the last 2 years
  • Severe anaphylactic reaction to breastmilk within the last 2 years
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • 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: NCT01569776

Locations
United States, California
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States, 92123
United States, Georgia
Georgia Pollens Clinical Research Centers Inc.
Albany, Georgia, United States, 31707
United States, Illinois
Allergy & Asthma Physicians
Hinsdale, Illinois, United States, 60521
United States, Indiana
Deaconess Clinic, Inc.
Evansville, Indiana, United States, 47713
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
ENT & Allergy Associates
Newburgh, New York, United States, 12550
United States, Texas
TTS Research
Boerne, Texas, United States, 78006
United States, Virginia
Clinical Research Partners
Richmond, Virginia, United States, 25233
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Anna Nowak-Wegrzyn, MD Mount Sinai Department of Pediatrics
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01569776     History of Changes
Other Study ID Numbers: 09.55.PED 
Study First Received: March 30, 2012
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Cow milk allergy
CMA

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

ClinicalTrials.gov processed this record on September 23, 2016