Status:
UNKNOWN
Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Beijing Children's Hospital
Children's Hospital of The Capital Institute of Pediatrics
Conditions:
Food Allergy in Children
Cow Milk Allergy
Eligibility:
All Genders
1-10 years
Phase:
NA
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 i...
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05406141
Start Date
March 30 2022
End Date
March 30 2023
Last Update
June 6 2022
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China