NCT03769051

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Cow's Milk Protein Allergy

Timeline

• Start date: 2015-06-20
• Primary completion: 2019-02-28
• Completion: 2019-04-01
• First posted: 2018-12-07
• Last updated: 2019-09-06