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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.
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).
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Cow's milk protein allergy infants in 0~6 months
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| Name | Affiliation | Role |
|---|---|---|
| Juan Zhang | Colleague | Study Director |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| 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 |