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Elemental 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: NCT01569776
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Food Hypersensitivity Other: Amino Acid formula Other: Commercially available Amino Acid Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. occurrence of allergic reactions [ Time Frame: 14 days ]
    occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

Secondary Outcome Measures :
  1. Digestive Tolerance [ Time Frame: one week ]
    gastrointestinal tolerance and formula intake recorded during the open challenge phase.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569776

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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
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Principal Investigator: Anna Nowak-Wegrzyn, MD Mount Sinai Department of Pediatrics

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Responsible Party: Nestlé Identifier: NCT01569776    
Other Study ID Numbers: 09.55.PED
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013
Keywords provided by Nestlé:
Cow milk allergy
Additional relevant MeSH terms:
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Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate