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

  • End date
    Mar 30, 2023
  • participants needed
  • sponsor
    Peking University Third Hospital
Updated on 20 June 2022


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).

Condition Food Allergy in Children, Cow Milk Allergy
Treatment Amino acid formula (Neocate Jr)
Clinical Study IdentifierNCT05406141
SponsorPeking University Third Hospital
Last Modified on20 June 2022


Yes No Not Sure

Inclusion Criteria

~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
Clear my responses

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