Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula

Study Overview
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Brief Summary
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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
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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).

Official Title
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Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula

Conditions
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Cow's Milk Protein Allergy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From baseline to AAF feeding for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | From baseline to AAF feeding for 6 months | 
| SCORAD score | An SCORAD evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | 
| Gastrointestinal symptom score | An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | 
| Respiratory symptom score | An Respiratory symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | 
| Comfort symptom score | An Comfort symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cow's Milk Protein allergy, Open Food Challenge test, Immune Tolerance, Amino Acid Formula