NCT03236207
Completed
Not Applicable
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Société des Produits Nestlé (SPN)12 sites in 1 country67 target enrollmentJuly 6, 2017
ConditionsCow Milk Allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cow Milk Allergy
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 67
- Locations
- 12
- Primary Endpoint
- allergic reaction post DBPCFC
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
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 Outcomes
- adverse events(1 week)
- stool characteristics(1 week)
- formula intake(1 week)
Study Sites (12)
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