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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cow Milk Allergy; Food Allergy in Children
• Intervention / Treatment: Dietary supplement: Amino acid formula (Neocate Jr)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zailing Li; Phone Number: +8613810095709; Email: topbj163@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Zailing Li; Phone Number: +8613810095709; Email: topbj163@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: children with food protein allergy	Dietary supplement: Amino 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing Children's Hospital; Children's Hospital of The Capital Institute of Pediatrics
• Investigators: Principal Investigator: Zailing Li, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 202107 V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No