Food Allergy in ChildrenNCT05406141
Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy
A study testing Amino acid formula (Neocate Jr) in people with Food Allergy in Children and Cow Milk Allergy, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Food Allergy in Children, Cow Milk Allergy
- What is being tested?
- Amino acid formula (Neocate Jr)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Zailing Li, +8613810095709, topbj163@sina.com
About this study
Official title: Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy
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.
Read the 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
- Being tested
- Amino acid formula (Neocate Jr)
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid formula (Neocate Jr)Dietary supplement
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)
| Study group | Role | What they receive |
|---|---|---|
| children with food protein allergy | Experimental | Not described Receives: Dietary Supplement: Amino acid formula (Neocate Jr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline SCORAD score to Neocate Jr feeding at day 28
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.
Measured: Change from baseline serum IgE to Neocate Jr feeding at day 28
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.
Measured: Change from baseline body weight to Neocate Jr feeding at day 28
Secondary outcomes (2)
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.
Measured: Change from baseline to Neocate Jr feeding at day 28
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.
Measured: Change from baseline to Neocate Jr feeding at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start30 Mar 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Zailing Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406141
- Sponsor's protocol ID
- 202107 V2.0
- Status last verified
- Feb 2022
- First submitted
- 14 Mar 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Sufficiency, Allergy Efficacy and Safety of an Amino Acid-Based Formula Neocate Jr in Children With Food Protein Allergy
- ClinicalTrials.gov ID
- NCT05406141
- Acronym / sponsor ID
- 202107 V2.0
- Conditions
- Food Allergy in Children, Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Chinese Academy of Medical Sciences
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with food protein allergy | Experimental | Dietary Supplement: Amino acid formula (Neocate Jr) |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Allergic to any ingredient in the recipe
- GI function failure
- Complete obstruction of the digestive tract
- Intractable diarrhea
- Noncooperation of neurologic or mental diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Dietary supplement | children with food protein allergy |
Primary outcome
SCORAD score
Time frame: Change from baseline SCORAD score to Neocate Jr feeding at day 28
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.
serum IgE
Time frame: Change from baseline serum IgE to Neocate Jr feeding at day 28
Serum IgE is selected as an indicator of allergy improvement, and will be measured by the investigator at baseline and day 28 for comparison.
weight for age
Time frame: Change from baseline body weight to Neocate Jr feeding at day 28
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.
2 secondary outcomes
weight for height
Time frame: Change from baseline to Neocate Jr feeding at day 28
hemoglobin, total blood protein, albumin, pre-albumin
Time frame: Change from baseline to Neocate Jr feeding at day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zailing Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid formula (Neocate Jr) in people with Food Allergy in Children and Cow Milk Allergy, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zailing Li (+8613810095709, topbj163@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD score (time frame: Change from baseline SCORAD score to Neocate Jr feeding at day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.