This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1\~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. The study will also evaluate the growth parameters, stool frequency and consistency, formula intake volume, gastrointestinal tolerance (including fussiness, flatulence, colic) and sleep disturbances, and any adverse events that may arise during the intervention period. This is a prospective, single-arm study including 50 young children at 1 hospital in China. Each participant will be followed for 90 days.
12 months≤ Age <36 months at enrollment.
Born at term at 37 ~ 42 weeks of gestation, with birth weight 2,500~4,000g.
Positive serum cow's-milk-specific IgE (sIgE) >0.35 kUA/L (>0.7 kIU/L), combined with a detailed medical history; or a positive skin prick test (SPT);
Positive result from a cow's milk protein elimination-challenge test;
History of severe cows-milk-induced allergic reaction, such as anaphylactic shock.
Underlying disease or history that may increase risk or affect gastrointestinal tolerance, growth, or development, including chronic systemic disease, congenital heart disease, chronic inflammatory bowel disease, malignant tumor, gastrointestinal malformation, or major congenital malformation.
Laboratory abnormalities judged by the investigator to make participation inappropriate.
Use of an extensively hydrolyzed formula or amino-acid formula within the preceding month.
Single group
Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
Other intervention* Avoidance of all foods and products containing cow's milk protein will be required; * An individualized diet will be selected and arranged according to the young children's usual eating habits, with dietary guidance provided by the investigator based on the young children's allergic status; * The intake of the investigational product will be recommended to be maintained at approximately 500 mL/day.
Change in investigator-reported allergy symptom scores
Change from baseline to D30 and D90 in investigator-assessed allergy symptoms in toddlers with diagnosed with or highly suspected cow's milk protein allergy, measured using four instruments.
Change in investigators measured or parent/caregiver-reported allergy symptom scores
Change from baseline to D30, D60 and D90 in investigators measured or parent/caregiver-reported symptoms, which will be analyzed according to improvement (reduction in score) or no improvement.
Change in z-scores for weight, length/height, and head circumference
Change in z-scores for weight, length/height, and head circumference calculated according to World Health Organization (WHO) growth standards. Differences between baseline, D30 and D90 will be summarized using descriptive statistics.
Change in stool characteristics
Parent-reported stool characteristics (consistency and color), stool frequencies and stool types will be summarized for each visit.
Stool Samples Test Results
Abnormalities in routine stool examination and fecal occult blood test.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
