Diagnostics of inflammatory bowel disease using fecal microbiota: Diagnostic markers and commercial potential
Year: 2010
Type: dissertation
Study design: Observational Study
Abstract: Establishing the diagnosis of Inflammatory Bowel Disease (IBD) with its two main sub forms \nCrohn‟s Disease (CD) and Ulcerative colitis (UC) are based on medical history, clinical \nevaluation, laboratory tests, endoscopy, radiology and histology. However no gold standard \nexists. The lack of appropriate diagnostic tools leads to delayed and incorrect treatment of \nIBD patients. A substantial amount of patients diagnosed as CD are later reclassified as UC \nand opposite. Also the type of colitis remains unclassified in many patients. In addition, non-\nIBD patients presenting with similar symptoms as IBD are unnecessarily investigated with \ninvasive tests leading to increased hospitals costs. \n \nThe cause of IBD is not yet completely described, but most evidence points to a combination \nof genetic predisposition, immunological factors, environmental triggers, and gastro intestinal \n(GI) microbes. However, neither the types of microbes responsible for the diseases nor \nchanges in the microbiota as a result of the diseases have been sufficiently identified. The aim \nof this thesis was to evaluate the potential of using the fecal microbiota for IBD diagnostics. \nThis was achieved through a combination of a literature study, lab study and investigations of \nthe commercial potential including a patent search. \n \nThe literature study revealed conflicting evidence related to the amounts of bacteria in IBD \npatients relative to controls. Nevertheless, a majority of the articles agreed in decreased \namounts of Clostridia species and increased amounts of Gammaproteobacteria species in the \nGI microbiota of IBD patients. \n \nThe lab study comprised an evaluation of a genetic test, GA-map™, commercialized by \nGenetic Analysis AS (GA). By using variable regions in the 16S rRNA gene, simultaneous \ndetection and identification of multiple bacteria in a complex mixture of DNA is possible. \nProbes and analytic methods are suitable for several types of diagnostic tests among other \nIBD. A sequence analysis of fecal samples from 152 IBD patients and 105 non-IBD controls \nwas performed. Significantly a probe detecting increased relative amounts of Proteobacteria \nand Bacteroidetes species was identified as a new possible diagnostic test for CD patients. \n \nA search in European and American patent databases revealed several patents related to IBD \ndiagnostics. Especially important, a patent application from George Mason University comprised claims referring to IBD diagnostics by using the microbial community of the \ndigestive tract and lumen. If issued, this application could influence the freedom to operate to \ncompanies focusing on bacterial markers in IBD diagnostics. Few other patents or patent \napplications from the search query include claims for identification of bacteria in fecal \nsamples. \n \nA concluding remark from examining the commercial potential of IBD diagnostics in this \nthesis is to tailor make a diagnostic test separating IBD from irritating bowel syndrome (IBS), \na common functional disease frequently confused with IBD. Based on estimations of price \nand profit per test, a €7Mill research budget was recommended for the normal case scenario. \nFinally it is concluded that development of a diagnostic test based on fecal microbiota has a \ncommercial potential within the proposed framework.
Author: C. Frøyland
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2489110725