Testing the Cow's Milk-Related Symptom Score (CoMiSSTM) for the Response to a Cow's Milk-Free Diet in Infants: A Prospective Study

Abstract

The diagnosis of cow's milk allergy (CMA) is particularly challenging in infants, especially with non-Immunoglobulin E (IgE)-mediated manifestations, and inaccurate diagnosis may lead to unnecessary dietary restrictions. The aim of this study was to assess the accuracy of the cow's milk-related symptom score (CoMiSS^TM) in response to a cow's milk-free diet (CMFD). We prospectively recruited 47 infants (median age three months) who had been placed on a CMFD due to persisting unexplained gastrointestinal symptoms. We compared data with 94 healthy controls (median age three months). The CoMiSS^TM score was completed at recruitment and while on the exclusion diet. In 19/47 (40%) cases a response to the diet occurred. At recruitment CoMiSS^TM was significantly higher in cases compared to controls (median score 8 vs. 3; p-value: <0.05), 9 cases had a score ≥12 and 8/9 normalized on CMFD. An oral milk challenge was performed in all 19 responders and six of these had a positive reaction to cow's milk (CM). In eight infants IgE allergy tests were positive. The receiver operation characteristic (ROC) curve identified a CoMISS^TM score of 9 to be the best cut-off value (84% sensitivity, 85% specificity, 80% positive (PPV) and 88% negative predictive value (NPV)) for the response to CMFD. We found CoMiSS^TM to be a useful tool to help identify infants with persisting gastrointestinal symptoms and suspected CMA that would benefit from CMFD.

Keywords: CoMiSSTM; cow’s milk allergy; cow’s milk-free diet; crying; gastrointestinal; hydrolysed formulas; infants; regurgitation.

Figure 1

Distribution of the cow’s milk-related symptom score (CoMiSS^TM) in symptomatic infants. T0: Time 0 (first visit).

Figure 2

Distribution of the CoMiSS^TM score in controls. T0: Time 0 (first visit).

Figure 3

Decrease of the CoMiSS^TM score in cases on cow‘s milk-free diet (CMFD) (T1). T0: Time 0 (first visit); T1: Time 1 (second visit after 2–4 weeks of cow‘s milk (CM) protein elimination diet).

Figure 4

Box plot distribution of CoMiSS^TM at baseline comparing infants who responded and did not respond to CMFD.

Figure 5

ROC curve of the CoMiSS^TM score.