The main purpose of this study is to evaluate efficacy and safety of an amino acid-based formula Neocate Jr in children with food protein allergy, and to evaluate nutrition sufficiency of Neocate Jr in 1 to 10 years old children with food protein allergy.
This is an open, self-controlled multi-center clinical study. Target population is 1～10 years old children allergic to cow's milk and/or food protein, confirmed by pediatrician. The study plans to recruit about 50 subjects to have an intervention period of 4 weeks. Data will be collected at baseline, week 1, 2 and 4. The hypothesis is that the amino acid formula (Neocate Jr) is effective in relieving food protein allergy symptoms, and meanwhile supporting normal growth in children with food protein allergy. Efficacy parameters are the the improvement of food protein allergy symptoms (SCORAD score, serum IgE), growth and development index (weight, height, weight for height), and nutrition related labs (such as hemoglobin, total blood protein, albumin, pre-albumin).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Use Neocate Jr for 4 weeks, either as sole source of nutrition or oral nutritional supplement: * Sole source of nutrition: as far as possible \>7 days, especially newly diagnosed allergy children * Oral nutritional supplement (Neocate Jr ≥50% of daily total energy and the rest provided by food)
Peking University Third Hospital
Beijing, China
RECRUITINGSCORAD score
SCORing Atopic Dermatitis (SCORAD) evaluation scale is selected as the indicator of allergy symptoms improvement, and will be evaluated by the investigator at each visit. The SCORAD score range is between 0 and 103, and lower scores mean a better outcome.
Time frame: Change from baseline SCORAD score to Neocate Jr feeding at day 28
serum IgE
Serum IgE is selected as an indicator of allergy improvement, and will be measured by the investigator at baseline and day 28 for comparison.
Time frame: Change from baseline serum IgE to Neocate Jr feeding at day 28
weight for age
Body weight for age is selected as the primary indicator of nutrition sufficiency, and will be measured by the investigator at each visit, and compared to World Health Organization (WHO) standard.
Time frame: Change from baseline body weight to Neocate Jr feeding at day 28
weight for height
Weight for height is selected as the an indicator of nutrition sufficiency, and will be evaluated by the investigator at each visit.
Time frame: Change from baseline to Neocate Jr feeding at day 28
hemoglobin, total blood protein, albumin, pre-albumin
Hemoglobin, total blood protein, albumin and pre-albumin are selected as indicators of nutrition sufficiency, and will be measured by the investigator at baseline and day 28.
Time frame: Change from baseline to Neocate Jr feeding at day 28
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