Cow 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 with HMOs
extensively hydrolyzed formula without HMOs
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 4 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| allergic reaction post DBPCFC | 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
| Measure | Time frame | Description |
|---|---|---|
| stool characteristics | 1 week | collected on daily diaries |
| formula intake | 1 week | amount of formula ingested daily |
| adverse events | 1 week | adverse events as reported by caregivers |
Countries
United States
Outcome results
None listed