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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 10 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05406141
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Third Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zailing Li
Principal Investigator Affiliation	Peking University Third Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy in Children, Cow Milk Allergy

Additional Details

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).

Arms & Interventions

Arms

Experimental: children with food protein allergy

Interventions

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)

Contact a Trial Team

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International Sites

Peking University Third Hospital, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, ,

Site Contact

Zailing Li

topbj163@sina.com

+8613810095709

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