The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children. Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers. The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
300
Peking University Third Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Children's Hospital of Fuzhou in Fujian province
Fuzhou, Fujian, China
The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.
Time frame: baseline, Week 2
CoMiSS and component scores
Time frame: baseline, Week 2, Week 4
Family history of atopy
Time frame: baseline
Method of delivery at birth
Time frame: baseline
Anthropometric measurements
Time frame: baseline
Volume intake of Alfamino formula every day
Time frame: baseline, week 2
Physician's assessment of the likelihood that a subject has CMPA
Time frame: baseline, week 2
The result of Oral food Challenge (OFC)
Time frame: week 2, Week 4
Compliance to elimination diet
Time frame: week 2
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The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Children's hospital of Zhengzhou
Zhengzhou, Henan, China
Hunan Children's Hospital
Hunan, Hunan, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Children's hospital of Shanxi Women health center of Shanxi
Taiyuan, Shanxi, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Maternal and child health care hospital of guangdong province
Guangzhou, China