Clinical trial NCT05406141: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergy in Children
Cow Milk Allergy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
name: Children's Hospital of The Capital Institute of Pediatrics
name: Chinese Academy of Medical Sciences
First posted: 2022-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: SCORAD score
timeFrame: Change from baseline SCORAD score to Neocate Jr feeding at day 28
measure: serum IgE
timeFrame: Change from baseline serum IgE to Neocate Jr feeding at day 28
measure: weight for age
timeFrame: Change from baseline body weight to Neocate Jr feeding at day 28
Secondary outcomes:
measure: weight for height
timeFrame: Change from baseline to Neocate Jr feeding at day 28
measure: hemoglobin, total blood protein, albumin, pre-albumin
timeFrame: Change from baseline to Neocate Jr feeding at day 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Zailing Li
role: PRINCIPAL_INVESTIGATOR
References: