Cow's Milk Protein Allergy
Conditions
Keywords
Cow's Milk Protein allergy, Open Food Challenge test, Immune Tolerance, Amino Acid Formula
Brief 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 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).
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative rate of open food challenge test | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAZ(height for age Z score) | From baseline until AAF feeding for 6 months | 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. |
| HCAZ(head circumference for age Z score) | From baseline to AAF feeding for 6 months | 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. |
| SCORAD score | From baseline to AAF feeding for 6 months | An SCORAD evaluation scale was evaluated by the investigator at each visit |
| WAZ(weight for age Z score) | From baseline to AAF feeding for 6 months | 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. |
| Respiratory symptom score | From baseline to AAF feeding for 6 months | An Respiratory symptom evaluation scale was evaluated by the investigator at each visit |
| Comfort symptom score | From baseline to AAF feeding for 6 months | An Comfort symptom evaluation scale was evaluated by the investigator at each visit |
| Gastrointestinal symptom score | From baseline to AAF feeding for 6 months | An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit |
Outcome results
None listed