NCT05406141

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Food Allergy in Children
• Cow Milk Allergy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-03-30
• Primary completion: 2022-12-30
• Completion: 2023-03-30
• First posted: 2022-06-06
• Last updated: 2022-06-06

Locations

1 site across 1 country: China