Status:
COMPLETED
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Lead Sponsor:
Peking University Third Hospital
Conditions:
Cow's Milk Protein Allergy
Eligibility:
All Genders
1-6 years
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 di...
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 paramet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03769051
Start Date
June 20 2015
End Date
April 1 2019
Last Update
September 6 2019
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