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Summary   Background  Dysbiosis is associated with many diseases, including irritable bowel syndrome ( IBS ), inflammatory bowel diseases ( IBD ), obesity and diabetes. Potential clinical impact of imbalance in the intestinal microbiota suggests need for new standardised diagnostic methods to facilitate microbiome profiling.    Aim  To develop and validate a novel diagnostic test using faecal samples to profile the intestinal microbiota and identify and characterise dysbiosis.    Methods  Fifty‐four  DNA  probes targeting ≥300 bacteria on different taxonomic levels were selected based on ability to distinguish between healthy controls and  IBS  patients in faecal samples. Overall, 165 healthy controls (normobiotic reference collection) were used to develop a dysbiosis model with a bacterial profile and Dysbiosis Index score output. The model algorithmically assesses faecal bacterial abundance and profile, and potential clinically relevant deviation in the microbiome from normobiosis. This model was tested in different samples from healthy volunteers and  IBS  and  IBD  patients ( n  =   330) to determine the ability to detect dysbiosis.    Results  Validation confirms dysbiosis was detected in 73% of  IBS  patients, 70% of treatment‐naïve  IBD  patients and 80% of  IBD  patients in remission, vs. 16% of healthy individuals. Comparison of deep sequencing and the GA‐map Dysbiosis Test, (Genetic Analysis AS, Oslo, Norway) illustrated good agreement in bacterial capture; the latter showing higher resolution by targeting pre‐determined highly relevant bacteria.    Conclusions  The  GA ‐map Dysbiosis Test identifies and characterises dysbiosis in  IBS  and  IBD  patients, and provides insight into a patient's intestinal microbiota. Evaluating microbiota as a diagnostic strategy may allow monitoring of prescribed treatment regimens and improvement in new therapeutic approaches.

Deviations in human gut microbiota: a novel diagnostic test for determining dysbiosis in patients with IBS or IBD