Non-interventional Research Clinical Research Program for Establishment of Milk Protein Allergy Oral Immune Tolerance

Study Purpose

The main purpose of this study was to observe the effect of amino acid formula powder on alleviating food allergies in infants; to evaluate the role of food avoidance and open-ended stimulation test in the diagnosis of food-allergic infants; to observe the allergic process in children with food allergy and to explore the criteria for diagnosis and treatment. The baby here refers to an infant between the ages of birth and 6 months of age. This study used a multicenter, prospective cohort study. Nine research units conducted research at the same time in different locations at different locations to ensure the scientific, authenticity, objectivity and reliability of the research conclusions. The number of design samples in this trial was 180. Considering the exit rate of no more than 10%, a total of 200 cases were completed.

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.	Observational
Eligible Ages	N/A - 6 Months
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age: 0 to 6 months A clinician suspects a child with food protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract or respiratory tract) Unable to breastfeed Vital signs are stable Legal guardian signs informed consent

Exclusion Criteria:

- children with congenital and hereditary metabolic diseases Digestive tract obstruction Children with immunodeficiency diseases Those who are allergic to known components of amino acid formula powder Researchers believe that it is not suitable for the group

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.	NCT03769051
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.
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.	Juan Zhang
Principal Investigator Affiliation	Colleague
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Milk Protein Allergy

Additional Details

This study used multi-center, prospective cohort study. Nine research units conducted the research in different locations according to the same program at the same time to ensure the scientific, authenticity, objectivity and reliability of the research conclusion. A total of 180 samples were designed for completion, taking into account the withdrawal rate of no more than 10%. The inclusion criteria age: 0 ~ 6 months clinical doctors diagnosed with food protein in children with allergic (any of the skin, gastrointestinal tract or respiratory symptoms or signs) Mother feeding Life is stable Legal custodian signed informed consent Exclusion criteria all kinds of congenital, children with inherited metabolic diseases Gastrointestinal obstruction Children with immune deficiency disease The mixture of ammonia base acid is known to be allergic Researchers identify as disqualified Exit criteria Where the child/parent or guardian has the right to withdraw from the study at any time for any reason; If the disease is aggravated within 48 hours of treatment, the patient should withdraw from the trial and be treated as invalid. Patients were asked to withdraw from the study if they were unable to continue to participate in the study, such as complications, adverse events, violations of protocol, or reasons for taking medication. Follow-up arrangement The observation period of each child was 6 months, followed up once a month. Follow up 1 year after observation. Validity index main outcome indicators: open food provocation tests positive incidence; secondary outcome indicators: body weight, body length, head circumference and arm muscle circumference; Improvement of food protein allergy symptoms (SCORAD, gi, respiratory, comfort scores). Clinical trial procedure All children should complete the following contents before entering the study: The parent/guardian signs a written informed consent Audit inclusion/exclusion criteria Molly I have general information Physical examination, including vital signs, weight, abdominal signs, systemic conditions Routine blood test, stool test, IgE test. The researcher should inform the child and his/her parent/guardian of the date of the next visit. If the child withdraws, the reason for withdrawal should be recorded in the case report form.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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