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

Cow Milk Allergy Clinical Trial

Official title:

Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406141
• Other study ID #: 202107 V2.0
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: February 2022
• Source: Peking University Third Hospital
• Contact: Zailing Li
• Phone: +8613810095709
• Email: topbj163[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• 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)

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Change from baseline to Neocate Jr feeding at day 28
Secondary	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.	Change from baseline to Neocate Jr feeding at day 28