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Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

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ClinicalTrials.gov Identifier: NCT02450643
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Condition or disease Intervention/treatment Phase
Cow's Milk Allergy Other: Test extensively hydrolyzed formula Other: Control extensively hydrolyzed formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Study Start Date : April 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Test then Control
Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Other: Test extensively hydrolyzed formula
extensively hydrolyzed formula made with a new enzyme

Other: Control extensively hydrolyzed formula
commercially available extensively hydrolyzed formula

Active Comparator: Control then Test
Subjects will perform a DBPCFC with the Control formula followed by the Test formula
Other: Test extensively hydrolyzed formula
extensively hydrolyzed formula made with a new enzyme

Other: Control extensively hydrolyzed formula
commercially available extensively hydrolyzed formula




Primary Outcome Measures :
  1. allergic reaction [ Time Frame: 2 hours post-DBPCFC ]
    number of children who react during a DBPCFC to either formula


Secondary Outcome Measures :
  1. stool characteristics [ Time Frame: 1 week ]
    stool descriptors as collected on daily diaries

  2. formula intake [ Time Frame: 1 week ]
    amount of formula ingested as collected on daily diaries

  3. adverse events [ Time Frame: 1 week ]
    any adverse event reported by caregivers



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Ages Eligible for Study:   2 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born at term (>36 weeks gestation)
  • 2 months to <4 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Children consuming mother's milk at the time of inclusion and during the trial
  • Any chromosomal or major congenital anomalies
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
  • Immunodeficiency
  • Receiving free amino acid formula
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02450643


Locations
United States, Arkansas
Atria Clinical Research
Little Rock, Arkansas, United States
United States, California
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
United States, Florida
All Children's Hospital
Saint Petersburg, Florida, United States
United States, Georgia
AeroAllergy
Savannah, Georgia, United States
United States, New York
Mt. Sinai
New York, New York, United States
ENT & Allergy Associates
Newburgh, New York, United States
United States, Ohio
Allergy and Sinus Relief Center/Great Lakes Medical research
Chardon, Ohio, United States
United States, Texas
Allergy Asthma Research Institute
Waco, Texas, United States
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Anna Nowak-Wegrzyn, MD Mt. Sinai

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02450643     History of Changes
Other Study ID Numbers: 14.24.CLI
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

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