Cow's Milk Allergy
Conditions
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.
Interventions
extensively hydrolyzed formula made with a new enzyme
commercially available extensively hydrolyzed formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| allergic reaction | 2 hours post-DBPCFC | number of children who react during a DBPCFC to either formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stool characteristics | 1 week | stool descriptors as collected on daily diaries |
| formula intake | 1 week | amount of formula ingested as collected on daily diaries |
| adverse events | 1 week | any adverse event reported by caregivers |
Countries
United States
Outcome results
None listed