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

Completed

• Conditions: Cow's Milk Protein Allergy

• Registration Number: NCT03769051
• Lead Sponsor: Peking University Third Hospital

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).

Study Timeline

• Study Start: 2015-06-20
• Status Verified: 2018-11
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2019-02-28
• Study Completion: 2019-04
• Last Update Submitted: 2019-09-01
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Gastrointestinal symptom score	From baseline to AAF feeding for 6 months	An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit
Respiratory symptom score	From baseline to AAF feeding for 6 months	An Respiratory symptom 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.
SCORAD score	From baseline to AAF feeding for 6 months	An SCORAD 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
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.