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

Peking University

Status: Unknown

Conditions: Food Allergy in Children; Cow Milk Allergy

Treatments: Dietary Supplement: Amino acid formula (Neocate Jr)

Study type: Interventional

Funder types: Other

Identifiers

NCT05406141

202107 V2.0

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

children with food protein allergy

Experimental group

Treatment:

Dietary Supplement: Amino acid formula (Neocate Jr)