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

Last updated: May 31, 2022
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergies & Asthma

Allergy

Allergy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05406141
202107 V2.0
  • Ages 1-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1～10 years old
  • The children with cow's milk/food protein allergy confirmed by pediatrician includingsequential feeding/newly diagnosed children, and children with EosinophilicEsophagitis, Gastroesophageal reflux disease, Food Protein-Induced EnterocolitisSyndrome (clinical symptoms and signs, IgE, oral food challenge, etc.)
  • Stable Vital Signs
  • Written informed consent from the children's parents/guardian

Exclusion

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 Design

Total Participants: 50
Study Start date:
March 30, 2022
Estimated Completion Date:
March 30, 2023

Study 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).

Connect with a study center

  • Peking University Third Hospital

    Beijing,
    China

    Active - Recruiting

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