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

Not Applicable

• Conditions: Food Allergy in Children; Cow Milk Allergy
• Interventions: Dietary Supplement: Amino acid formula (Neocate Jr)

• Registration Number: NCT05406141
• Lead Sponsor: Peking University Third Hospital

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).

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-03-14
• Study Start: 2022-03-30
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-06
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
children with food protein allergy	Amino acid formula (Neocate Jr)	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China