Food Hypersensitivity
Conditions
Keywords
Cow's Milk Allergy, CMA
Brief summary
The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.
Interventions
OTHERExtensively hydrolyzed, whey protein infant formula
New hydrolyzed formula
OTHERExtensively hydrolyzed, casein protein infant formula
Commercially available hydrolyzed infant formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Born at term (\>36 weeks gestation) 2. Two (2) months to ≤ 12 years of age at enrollment 3. Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by: 1. Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and \[detectable serum milk-specific IgE (\>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm\]), OR 2. Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR 3. Results of laboratory tests highly predictive of clinical reactivity to milk * Serum milk IgE ≥15 \[kIU/L\]or ≥ 5 \[kIU/L if younger than 1 year OR, * Skin prick tests mean wheal \>10 mm 4. Otherwise healthy 5. If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled 6. Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase 7. Having obtained his/her legal representative's informed consent.
Exclusion criteria
1. Children consuming mother's milk at the time of inclusion and during the trial 2. Any chromosomal or major congenital anomalies 3. Any major gastrointestinal disease or abnormalities other than CMA 4. Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable) 5. Immunodeficiency 6. Receiving free amino acid formula 7. Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable) 8. Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay) 9. Unstable asthma 10. Severe uncontrolled eczema 11. Recent ( within the last 3 months) severe anaphylactic reaction to milk 12. Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol 13. Currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoallergenicity | 14 Days | To demonstrate that the test formula does not provoke allergenic activity |
Secondary
| Measure | Time frame |
|---|---|
| Digestive Tolerance | 1 Week |
Countries
United States
Outcome results
None listed