Protocol for the validation of sensitivity and specificity of the Cow’s Milk-related Symptom Score (CoMiSS) against open food challenge in a single-blinded, prospective, multicentre trial in infants

摘要: Introduction The symptoms of cow’s milk protein allergy (CMPA) in infancy can be non-specific which may delay a correct diagnosis and cause adverse clinical outcomes. non-IgE-mediated CMPA is particularly complex as it involves 2 to 4 week elimination diet followed by oral food challenge (OFC). Cow’s Milk-related Symptom Score (CoMiSS) resource for primary healthcare providers aims increase awareness facilitate an earlier diagnosis. aim the present study assess if CoMiSS used potential diagnostic tool infants with suspected CMPA. Methods analysis Exclusively formula-fed aged 0–6 months presenting suggestive will included this prospective, multicentre trial conducted 10 centres China. All commence 2-week amino acid-based formula (AAF) while eliminating all cow from their diets. After AAF treatment period, undergo open OFC hospital standard formula, home another 2 weeks. Clinical documented on standardised symptom scorecards. determined at entry (CoMiSS 1, before start AAF), after 2 weeks 2, OFC) further period or when reappear 3). Weight length measured each visit. difference between 1 predictor outcome also assessed. accuracy baseline calculated. Ethics dissemination was approved Hunan Children’s Hospital Medical Committee, Hunan, findings submitted publication peer-reviewed journal paediatric nutrition gastroenterology. Abstracts relevant national international conferences. Trial registration number NCT03004729; Pre-results.