Clostridium difficile-specific biomarkers

• Research type

  Research Study

• Full title

  Development of Clostridium difficile specific biomarkers for detection of the organism in human clinical stool samples.

• IRAS ID

  138226

• Contact name

  Nigel Ternan

• Contact email

  ng.ternan@ulster.ac.uk

• Sponsor organisation

  University of Ulster

• Research summary

  Clostridium difficile is a Gram-positive bacterium that in healthy individuals is relatively benign. However, antibiotic therapy can often disrupt the normal gut microbiota and in this situation, C. difficile can thrive. As a result of C. difficile’s ability to produce toxins that inflame the gut lining, C. difficile infection (CDI) leads to a range of symptoms ranging from fever, cramps and mild diarrhoea to pseudomembranous colitis and potentially life threatening toxic megacolon.
  The most common methods used in hospitals for detecting C. difficile are enzyme immunoassays which detect proteins specific to C. difficile, such as glutamate dehydrogenase (GDH), followed by confirmation of the presence of toxin A and/or B. and additional PCR tests to confirm presence of toxin genes in cases where patients present with low toxin titre. A single molecular assay that confirmed presence of toxigenic C. difficile would be of value. Therefore we believe there is a pressing need for the development of a rapid, toxin-independent, specific and sensitive one step multipoint test (OSMPT) for the presence of C. difficile.

  In previous work we identified 18 novel, toxin-independent biomarker genes unique to strains of C. difficile using PCR. Consequently we have selected the 8 strongest candidate biomarker genes and propose to test them on 500 archived stool samples (anonymised) which have a known clinical outcome (approximately 300 positive stool samples, 200 negative stool samples). As a direct consequence of the proposed work, we will be able to establish the predictive value of our novel biomarker targets for identifying C. difficile.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  13/LO/1765

• Date of REC Opinion

  1 Nov 2013

• REC opinion

  Favourable Opinion