Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy

Conditions
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Food Allergy in Children, Cow Milk Allergy

Intervention / Treatment
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* Dietary Supplement: Amino acid formula (Neocate Jr)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children with food protein allergy<br> | Dietary Supplement: Amino acid formula (Neocate Jr)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD 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. | 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. | 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. | Change from baseline body weight to Neocate Jr feeding at day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline to Neocate Jr feeding at day 28 |