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

BMJ Open
Yvan Vandenplason behalf the Chinese CoMiSS Investigator Team.

Abstract

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. The diagnosis of non-IgE-mediated CMPA is particularly complex as it involves a 2 to 4 week elimination diet followed by oral food challenge (OFC). The Cow's Milk-related Symptom Score (CoMiSS) is a clinical resource for primary healthcare providers which aims to increase awareness of CMPA symptoms to facilitate an earlier diagnosis. The aim of the present study is to assess if the CoMiSS can be used as a potential diagnostic tool in infants with suspected CMPA. Exclusively formula-fed infants aged 0-6 months presenting with symptoms suggestive of CMPA will be included in this prospective, multicentre trial which will be conducted in 10 centres in China. All infants will commence a 2-week trial of an amino acid-based formula (AAF) while eliminating all cow milk protein from their diets. After the AAF treatment period, infants will undergo an open OFC in hospital with standard cow's milk formula, followed by an open home challenge for another 2 weeks. Clinical symptoms will be documented on standardised symptom scorecards. The CoMiSS will be determined at study entry (CoMiSS 1,...Continue Reading

Citations

Mar 21, 2020·Current Opinion in Allergy and Clinical Immunology·Alessandro Fiocchi, Motohiro Ebisawa
Apr 30, 2020·Current Opinion in Allergy and Clinical Immunology·Alessandro Fiocchi, Motohiro Ebisawa
Mar 25, 2020·Pediatric Gastroenterology, Hepatology & Nutrition·Karolina BigorajskaHania Szajewska
Jan 5, 2021·Journal of Pediatric Gastroenterology and Nutrition·Ana Muñoz-UrribarriYovani M Condorhuamán
Jul 29, 2021·Pediatric Gastroenterology, Hepatology & Nutrition·Anna Kozłowska-JalowskaHania Szajewska
Jul 29, 2021·Pediatric Gastroenterology, Hepatology & Nutrition·Yvan VandenplasUNKNOWN Mosaic Study Investigator Group

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Methods Mentioned

BETA
Caesarean section

Software Mentioned

R
Cytel
CoMiSS

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