Cow Milk Allergy, Food Allergy in Children
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTAmino acid formula (Neocate Jr)
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)
Sponsors
Beijing Children's Hospital
Children's Hospital of The Capital Institute of Pediatrics
Chinese Academy of Medical Sciences
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 1～10 years old * The children with cow's milk/food protein allergy confirmed by pediatrician including sequential feeding/newly diagnosed children, and children with Eosinophilic Esophagitis, Gastroesophageal reflux disease, Food Protein-Induced Enterocolitis Syndrome (clinical symptoms and signs, IgE, oral food challenge, etc.) * Stable Vital Signs * Written informed consent from the children's parents/guardian
Exclusion criteria
* Allergic to any ingredient in the recipe * GI function failure * Complete obstruction of the digestive tract * Intractable diarrhea * Noncooperation of neurologic or mental diseases * Disapproval of pediatricians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCORAD score | Change from baseline SCORAD score to Neocate Jr feeding at day 28 | 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. |
| serum IgE | Change from baseline serum IgE to Neocate Jr feeding at day 28 | Serum IgE is selected as an indicator of allergy improvement, and will be measured by the investigator at baseline and day 28 for comparison. |
| weight for age | Change from baseline body weight to Neocate Jr feeding at day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight for height | Change from baseline to Neocate Jr feeding at day 28 | Weight for height is selected as the an indicator of nutrition sufficiency, and will be evaluated by the investigator at each visit. |
| hemoglobin, total blood protein, albumin, pre-albumin | Change from baseline to Neocate Jr feeding at day 28 | 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. |
Countries
China
Contacts
Primary ContactZailing Li
Outcome results
None listed