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

Cow's Milk Protein Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769051
• Other study ID #: 20180402 v1.3
• Status: Completed
• Start date: June 20, 2015
• Est. completion date: April 2019

Study information

• Verified date: November 2018
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Protein Allergy
• Hypersensitivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	SCORAD score	An SCORAD evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Secondary	Gastrointestinal symptom score	An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Secondary	Respiratory symptom score	An Respiratory symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months
Secondary	Comfort symptom score	An Comfort symptom evaluation scale was evaluated by the investigator at each visit	From baseline to AAF feeding for 6 months