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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2023-03-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Food Allergy in Children Cow Milk Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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children with food protein allergy

Group Type EXPERIMENTAL

Amino acid formula (Neocate Jr)

Intervention Type 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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No