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

Peking University Third Hospital200 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Cow's Milk Protein Allergy

Eligibility

Sex: ALLMin age: 1 DayMax age: 6 Months

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: From baseline to AAF feeding for 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From baseline to AAF feeding for 6 months

SCORAD score

An SCORAD evaluation scale was evaluated by the investigator at each visit

Time frame: From baseline to AAF feeding for 6 months

Data from ClinicalTrials.gov

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