Status:
COMPLETED
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Cow Milk Allergy
Eligibility:
All Genders
2-4 years
Phase:
NA
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03236207
Start Date
July 6 2017
End Date
November 6 2018
Last Update
January 30 2019
Active Locations (12)
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1
Hoag Medical Group
Huntington Beach, California, United States, 92648
2
Stanford University
Mountain View, California, United States, 94040
3
Clinical Research Institute
Plymouth, Minnesota, United States, 55441
4
Midwest Clinical Research
St Louis, Missouri, United States, 63141