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

Peking University

Status: Completed

Conditions: Cow's Milk Protein Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT03769051

20180402 v1.3

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

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.