Food Hypersensitivity
Conditions
Keywords
Cow milk allergy, CMA
Brief summary
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
Interventions
Amino Acid baby formula
Hypoallergenic Baby formula
Sponsors
Study design
Eligibility
Inclusion criteria
* Born at term (\>36 weeks gestation) * 2 months to ≤12 years of age at enrollment * Documented CMA within 6 months prior to enrollment * Otherwise healthy * Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable * Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase * 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 * Any major gastrointestinal disease or abnormalities other than CMA * Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay) * Immunodeficiency * Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted) * Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted) * Unstable asthma * Severe uncontrolled eczema * Severe anaphylactic reaction to milk within the last 2 years * Severe anaphylactic reaction to breastmilk within the last 2 years * 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 |
|---|---|---|
| occurrence of allergic reactions | 14 days | occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digestive Tolerance | one week | gastrointestinal tolerance and formula intake recorded during the open challenge phase. |
Countries
United States