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Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

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.
 
ClinicalTrials.gov Identifier: NCT03236207
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : January 30, 2019
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 Milk Allergy Other: Test extensively hydrolyzed formula Other: Control extensively hydrolyzed formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : November 6, 2018
Actual Study Completion Date : November 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Test infant formula
Test non-commercial extensively hydrolyzed infant formula with HMOs
Other: Test extensively hydrolyzed formula
extensively hydrolyzed formula with HMOs

Active Comparator: Control infant formula
Control non-commercial extensively hydrolyzed infant formula without HMOs
Other: Control extensively hydrolyzed formula
extensively hydrolyzed formula without HMOs




Primary Outcome Measures :
  1. allergic reaction post DBPCFC [ Time Frame: 2 hours ]
    subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators


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

  2. formula intake [ Time Frame: 1 week ]
    amount of formula ingested daily

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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Anaphylaxis to any food
  • 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): NCT03236207


Locations
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United States, California
Hoag Medical Group
Huntington Beach, California, United States, 92648
Stanford University
Mountain View, California, United States, 94040
United States, Minnesota
Clinical Research Institute
Plymouth, Minnesota, United States, 55441
United States, Missouri
Midwest Clinical Research
Saint Louis, Missouri, United States, 63141
United States, New Mexico
Breathe America
Albuquerque, New Mexico, United States, 87109
United States, New York
Northwell Health System
Great Neck, New York, United States, 11021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Oklahoma
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States, 71320
United States, South Carolina
Carolina ENT
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Memphis & Shelby County Pediatrics
Memphis, Tennessee, United States, 38116
United States, Texas
Houston Clinical Research Associates
Houston, Texas, United States, 77090
Allergy Asthma Research Institute
Waco, Texas, United States, 76633
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Anna Nowak-Wegrzyn, MD Mt Sinai

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03236207     History of Changes
Other Study ID Numbers: 16.16.CLI
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases