Cow's Milk Protein AllergyNCT03769051
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
An observational study of Cow's Milk Protein Allergy, run by Peking University Third Hospital.
Trial summary
The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein… Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2015to Apr 2019
- Phase
- Observational
- 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 day to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Cow's milk protein allergy infants in 0~6 months
Who may be able to join
- Age: 0 to 6 months;
- Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
- Unable to breastfeed;
- Vital signs are stable;
- Legal guardian has signed the informed consent.
Who cannot join
- Subject with congenital and hereditary metabolic diseases;
- Digestive tract obstruction;
- Subject with immunodeficiency diseases;
- Subject who is allergic to known components of amino acid formula powder;
- The investigator judges it is not suitable for the subject to participate in this study.
About this study
The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.
Read the detailed description
This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
- Conditions
- Cow's Milk Protein Allergy
- Keywords
- Cow's Milk Protein allergy, Open Food Challenge test, Immune Tolerance, Amino Acid Formula
- Medical subject headings
- Milk Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative rate of open food challenge test
Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF
Measured: From baseline to AAF feeding for 6 months
Secondary outcomes (7)
WAZ(weight for age Z score)
Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.
Measured: From baseline to AAF feeding for 6 months
HAZ(height for age Z score)
Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.
Measured: From baseline until AAF feeding for 6 months
HCAZ(head circumference for age Z score)
Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.
Measured: From baseline to AAF feeding for 6 months
SCORAD score
An SCORAD evaluation scale was evaluated by the investigator at each visit
Measured: From baseline to AAF feeding for 6 months
Gastrointestinal symptom score
An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit
Measured: From baseline to AAF feeding for 6 months
Respiratory symptom score
An Respiratory symptom evaluation scale was evaluated by the investigator at each visit
Measured: From baseline to AAF feeding for 6 months
Comfort symptom score
An Comfort symptom evaluation scale was evaluated by the investigator at each visit
Measured: From baseline to AAF feeding for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start20 Jun 2015
- Primary completion28 Feb 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Zhang, Study director, Colleague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769051
- Sponsor's protocol ID
- 20180402 v1.3
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
- ClinicalTrials.gov ID
- NCT03769051
- Acronym / sponsor ID
- 20180402 v1.3
- Conditions
- Cow's Milk Protein Allergy
- Keywords
- Cow's Milk Protein allergy, Open Food Challenge test, Immune Tolerance, Amino Acid Formula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Jun 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 7 Dec 2018 (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 was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.
Detailed description
This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cow's milk protein allergy infants in 0~6 months
Key inclusion criteria (5 listed)
- Age: 0 to 6 months;
- Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)
- Unable to breastfeed;
- Vital signs are stable;
- Legal guardian has signed the informed consent.
Key exclusion criteria (5 listed)
- Subject with congenital and hereditary metabolic diseases;
- Digestive tract obstruction;
- Subject with immunodeficiency diseases;
- Subject who is allergic to known components of amino acid formula powder;
- The investigator judges it is not suitable for the subject to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Negative rate of open food challenge test
Time frame: From baseline to AAF feeding for 6 months
Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF
7 secondary outcomes
WAZ(weight for age Z score)
Time frame: From baseline to AAF feeding for 6 months
HAZ(height for age Z score)
Time frame: From baseline until AAF feeding for 6 months
HCAZ(head circumference for age Z score)
Time frame: From baseline to AAF feeding for 6 months
SCORAD score
Time frame: From baseline to AAF feeding for 6 months
Gastrointestinal symptom score
Time frame: From baseline to AAF feeding for 6 months
Respiratory symptom score
Time frame: From baseline to AAF feeding for 6 months
Comfort symptom score
Time frame: From baseline to AAF feeding for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Undecided
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GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
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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.
Juan Zhang study director
Colleague
Questions about this trial
What is this clinical trial studying?
An observational study of Cow's Milk Protein Allergy, run by Peking University Third Hospital.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative rate of open food challenge test (time frame: From baseline to AAF feeding for 6 months). 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 Sep 2019.