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

Primary Purpose

Food Allergy in Children, Cow Milk Allergy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amino acid formula (Neocate Jr)
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy in Children

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

children with food protein allergy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 14, 2022
Last Updated
May 31, 2022
Sponsor
Peking University Third Hospital
Collaborators
Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05406141
Brief Title
Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy
Official Title
Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy in Children, Cow Milk Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
children with food protein allergy
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino acid formula (Neocate Jr)
Intervention Description
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)
Primary Outcome Measure Information:
Title
SCORAD score
Description
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.
Time Frame
Change from baseline SCORAD score to Neocate Jr feeding at day 28
Title
serum IgE
Description
Serum IgE is selected as an indicator of allergy improvement, and will be measured by the investigator at baseline and day 28 for comparison.
Time Frame
Change from baseline serum IgE to Neocate Jr feeding at day 28
Title
weight for age
Description
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.
Time Frame
Change from baseline body weight to Neocate Jr feeding at day 28
Secondary Outcome Measure Information:
Title
weight for height
Description
Weight for height is selected as the an indicator of nutrition sufficiency, and will be evaluated by the investigator at each visit.
Time Frame
Change from baseline to Neocate Jr feeding at day 28
Title
hemoglobin, total blood protein, albumin, pre-albumin
Description
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.
Time Frame
Change from baseline to Neocate Jr feeding at day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zailing Li
Phone
+8613810095709
Email
topbj163@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zailing Li
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zailing Li
Phone
+8613810095709
Email
topbj163@sina.com

12. IPD Sharing Statement

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

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