Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
1 other identifier
interventional
83
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 7, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 1, 2017
July 1, 2017
2.2 years
May 7, 2015
July 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
allergic reaction
number of children who react during a DBPCFC to either formula
2 hours post-DBPCFC
Secondary Outcomes (3)
stool characteristics
1 week
formula intake
1 week
adverse events
1 week
Study Arms (2)
Test then Control
ACTIVE COMPARATORSubjects will perform a DBPCFC with the Test formula followed by the Control formula
Control then Test
ACTIVE COMPARATORSubjects will perform a DBPCFC with the Control formula followed by the Test formula
Interventions
extensively hydrolyzed formula made with a new enzyme
commercially available extensively hydrolyzed formula
Eligibility Criteria
You may qualify if:
- Born at term (\>36 weeks gestation)
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Atria Clinical Research
Little Rock, Arkansas, United States
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
All Children's Hospital
St. Petersburg, Florida, United States
AeroAllergy
Savannah, Georgia, United States
Mt. Sinai
New York, New York, United States
ENT & Allergy Associates
Newburgh, New York, United States
Allergy and Sinus Relief Center/Great Lakes Medical research
Chardon, Ohio, United States
Allergy Asthma Research Institute
Waco, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Nowak-Wegrzyn, MD
Mt. Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2015
First Posted
May 21, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07