Cow's Milk Protein Allergy Clinical Trial
Official title:
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
NCT number | NCT03769051 |
Other study ID # | 20180402 v1.3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 20, 2015 |
Est. completion date | April 2019 |
Verified date | November 2018 |
Source | Peking University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | SCORAD score | An SCORAD evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | |
Secondary | Gastrointestinal symptom score | An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | |
Secondary | Respiratory symptom score | An Respiratory symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months | |
Secondary | Comfort symptom score | An Comfort symptom evaluation scale was evaluated by the investigator at each visit | From baseline to AAF feeding for 6 months |
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