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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03769051
Other study ID # 20180402 v1.3
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02953223 - A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Completed NCT03085134 - Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides N/A
Recruiting NCT06288503 - Hydrolysed Rice Formula Study N/A
Completed NCT06273371 - Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain