Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Primary Purpose
Cow's Milk Allergy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test extensively hydrolyzed formula
Control extensively hydrolyzed formula
Sponsored by
About this trial
This is an interventional other trial for Cow's Milk Allergy
Eligibility 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.
Sites / Locations
- Atria Clinical Research
- Allergy and Asthma Associates of Southern California
- All Children's Hospital
- AeroAllergy
- Mt. Sinai
- ENT & Allergy Associates
- Allergy and Sinus Relief Center/Great Lakes Medical research
- Allergy Asthma Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test then Control
Control then Test
Arm Description
Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Subjects will perform a DBPCFC with the Control formula followed by the Test formula
Outcomes
Primary Outcome Measures
allergic reaction
number of children who react during a DBPCFC to either formula
Secondary Outcome Measures
stool characteristics
stool descriptors as collected on daily diaries
formula intake
amount of formula ingested as collected on daily diaries
adverse events
any adverse event reported by caregivers
Full Information
NCT ID
NCT02450643
First Posted
May 7, 2015
Last Updated
July 31, 2017
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT02450643
Brief Title
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Official Title
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test then Control
Arm Type
Active Comparator
Arm Description
Subjects will perform a DBPCFC with the Test formula followed by the Control formula
Arm Title
Control then Test
Arm Type
Active Comparator
Arm Description
Subjects will perform a DBPCFC with the Control formula followed by the Test formula
Intervention Type
Other
Intervention Name(s)
Test extensively hydrolyzed formula
Intervention Description
extensively hydrolyzed formula made with a new enzyme
Intervention Type
Other
Intervention Name(s)
Control extensively hydrolyzed formula
Intervention Description
commercially available extensively hydrolyzed formula
Primary Outcome Measure Information:
Title
allergic reaction
Description
number of children who react during a DBPCFC to either formula
Time Frame
2 hours post-DBPCFC
Secondary Outcome Measure Information:
Title
stool characteristics
Description
stool descriptors as collected on daily diaries
Time Frame
1 week
Title
formula intake
Description
amount of formula ingested as collected on daily diaries
Time Frame
1 week
Title
adverse events
Description
any adverse event reported by caregivers
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegrzyn, MD
Organizational Affiliation
Mt. Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atria Clinical Research
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Allergy and Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
AeroAllergy
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Mt. Sinai
City
New York
State/Province
New York
Country
United States
Facility Name
ENT & Allergy Associates
City
Newburgh
State/Province
New York
Country
United States
Facility Name
Allergy and Sinus Relief Center/Great Lakes Medical research
City
Chardon
State/Province
Ohio
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
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