Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Société des Produits Nestlé (SPN)
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
