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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-20

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cow's Milk Protein Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No