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

NCT05406141 | Unknown

• 1 other identifier: 202107 V2.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy in Children; Cow Milk Allergy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• weight for height

  Change from baseline to Neocate Jr feeding at day 28

• hemoglobin, total blood protein, albumin, pre-albumin

  Change from baseline to Neocate Jr feeding at day 28

Study Arms (1)

children with food protein allergy

EXPERIMENTAL

Dietary Supplement: Amino acid formula (Neocate Jr)

Interventions

Amino acid formula (Neocate Jr) DIETARY_SUPPLEMENT

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)

children with food protein allergy

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ～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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Children's Hospital: collaborator
• Children's Hospital of The Capital Institute of Pediatrics: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zailing Li

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zailing Li

CONTACT

+8613810095709; topbj163@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: June 6, 2022
• Study Start: March 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-02

Locations

CN (1)