New method to detect systemic MAP infections in Crohn's patients, V1

  • Research type

    Research Study

  • Full title

    Identification of Crohn’s disease cases with systemic Mycobacterium avium subsp. paratuberculosis (MAP) infections using the novel RAPIDvMAP assay

  • IRAS ID

    339897

  • Contact name

    Irene R Grant

  • Contact email

    i.grant@rapid-myco.com

  • Sponsor organisation

    Rapid-Myco Technologies Limited

  • Duration of Study in the UK

    0 years, 11 months, 30 days

  • Research summary

    Mycobacterium avium subsp. paratuberculosis (MAP) has long been linked with Crohn’s disease, although its precise role in the disease remains uncertain; largely due to the lack of diagnostics with sufficient speed, detection sensitivity and quantitative ability to detect the pathogen in human samples. A recently developed novel one-day phage-based method (RAPIDvMAP assay, Rapid-Myco Technologies Ltd) for detecting viable MAP in blood theoretically offers these test attributes, but feasibility of using it to detect viable MAP in human blood samples needs to be determined. During the feasibility study we propose to test buffy coat samples separated from the blood of Crohn’s patients (newly diagnosed and those with established disease) using the RAPIDvMAP assay in parallel with liquid and solid mycobacterial culture. Phage assay results will provide information on the prevalence of viable MAP in the blood of Crohn’s patients attending a NI hospital Inflammatory Bowel Disease clinic. Parallel culture results will permit an evaluation of the performance of the more rapid phage-based assay relative to culture ('gold standard'). Any MAP isolates obtained will be stored for future testing of susceptibility to antibiotics currently being used by some gastroenterologists in other parts of the world to treat MAP-infected Crohn’s patients. Ultimately, this study will: (1) provide new information on the prevalence of systemic MAP infection in a cohort of NI Crohn’s patients, and (2) provide information on the suitability of the novel phage-based RAPIDvMAP assay as a quick test for systemic MAP infection in humans.

  • REC name

    Wales REC 6

  • REC reference

    24/WA/0143

  • Date of REC Opinion

    20 Aug 2024

  • REC opinion

    Favourable Opinion