Observational Study of the Cow’s Milk-related Symptom Score (CoMiSS)
Research type
Research Study
Full title
In Use Observational Study of the Cow’s Milk-related Symptom Score (CoMiSS) In 4 EU Countries
IRAS ID
229190
Contact name
Niten Makwana
Contact email
Sponsor organisation
Nestlé
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Diagnosing cow’s-milk protein allergy (CMPA) may be challenging. Gastrointestinal (GI) manifestations of CMPA are nonspecific and there are no specific diagnostic markers. The majority of affected children have one or more symptoms involving one or more organs system, mainly in the gastrointestinal tract or the skin. Moreover, functional GI symptoms are very prevalent in infants. Depending on the awareness of physicians, symptoms may be attritubed or not to ingestion of cow’s milk. The CoMiSS – which considers general manifestations, dermatological, gastrointestinal and respiratory symptoms –has been developed as an awareness tool to help primary care providers to recognize cow’s milk-related symptoms in infants and young children. The CoMiSS tool calculates a symptom-based score that can be used to support diagnostic decision-making. This tool has already been used in several clinical trials but no data are available in primary care practice.
There is no investigational nutrition product. The CoMiSS is based on a questionnaire that captures the characteristics of five distinct signs or symptoms including: - crying (time per day), - regurgitation (severity and volume per day), - stools (characteristics according to Bristol Scale), - skin symptoms, including Atopic Eczema (extent and severity) and urticaria - respiratory symptoms (severity). A score is assigned to each category depending on severity. The sum results in a total score that can range from 0 to 33. A total score of ≥ 12 suggests that the symptoms are likely Cow’s Milk related.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0389
Date of REC Opinion
9 Nov 2017
REC opinion
Further Information Favourable Opinion