Loading clinical trials...

Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula | Clinical Trials | Clareo Health

COMPLETED

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

NCT03769051•Peking University Third Hospital

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).

Eligibility

Age

0 - 0 years

Sex

ALL

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.

Key Dates

Start Date

June 20, 2015

Primary Completion Date

February 28, 2019

Completion Date

April 1, 2019

Last Updated

September 6, 2019

Enrollment

200

ACTUAL participants

Conditions

Cow's Milk Protein Allergy

Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy

NCT06633289

Cow's Milk Protein Allergy

View study

NOT_YET_RECRUITINGNA

Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)

NCT07484035

Cow's Milk Protein Allergy (CMPA)

View study

NOT_YET_RECRUITINGNA

Dietary Restriction Efficiency Assessment in CMPA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions