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

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.

Study Overview

• Status: Completed
• Conditions: Cow's Milk Protein Allergy

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).

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cow's milk protein allergy infants in 0~6 months

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative rate of open food challenge test	Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF	From baseline to AAF feeding for 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WAZ(weight for age Z score)	Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.	From baseline to AAF feeding for 6 months
HAZ(height for age Z score)	Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.	From baseline until AAF feeding for 6 months
HCAZ(head circumference for age Z score)	Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.	From baseline to AAF feeding for 6 months
SCORAD score	An SCORAD evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Gastrointestinal symptom score	An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Respiratory symptom score	An Respiratory symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Comfort symptom score	An Comfort symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Juan Zhang, colleague

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2015
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 1, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Immune Tolerance; Cow's Milk Protein allergy; Open Food Challenge test; Amino Acid Formula
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 20180402 v1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No