Microbial dYsbiosis in the pathogenesis of Rheumatoid Arthritis (MyRA)

  • Research type

    Research Study

  • Full title

    Microbial dYsbiosis in the pathogenesis of Rheumatoid Arthritis: using metagenomics to predict methotrexate efficacy (MyRA)

  • IRAS ID

    238047

  • Contact name

    Simon Carding

  • Contact email

    simon.carding@quadram.ac.uk

  • Sponsor organisation

    Quadram Institute Bioscience

  • Clinicaltrials.gov Identifier

    NCT03802890

  • Clinicaltrials.gov Identifier

    NHS R&D reference number, 62-05-18 (see Appendix 16)

  • Duration of Study in the UK

    1 years, 6 months, 30 days

  • Research summary

    Rheumatoid arthritis (RA) affects approximately 1% of the world population. The cause of the disease is unknown. Recent studies have highlighted the gut microbiota; i.e. the collection of bacteria, viruses and other microorganisms in the gut, as being important in RA progression. It appears that the gut microbiota is in a state of dysbiosis in RA. For instance, there is a reduction in microbial diversity and an outgrowth of potentially harmful species. This can have an impact on intestinal permeability and immune functions, potentially leading to inflammation and the development of RA (the gut-joint axis). Gut microbiota could also impact on how well someone responds to RA treatments like methotrexate, and it may therefore be possible to predict how someone will respond to treatment, or to implement complimentary therapies like probiotics or diet to improve response. This project; funded by the University of East Anglia and the charity Action Arthritis and in collaboration with Quadram Institute Bioscience and Norwich and Norfolk University Hospital (NNUH), will investigate the gut-joint axis further by collecting blood and stool samples within the first 6 months of a patient’s normal treatment pathway. Patients with early RA will be sampled before and after treatment with methotrexate to identify correlations between the microbiota and treatment response, and longitudinal microbiome alterations associated with methotrexate. In addition, dietary and lifestyle information will be collected to explore if this can account for response-associated microbiota alterations. Participants will be identified via the Norfolk Arthritis Register, and four study visits will take place at NNUH, coinciding with routine appointments, between August 2018 and February 2020. Samples and data will be analysed at the Norwich Research Park, and stored long-term at the on-site Biorepository. The results of this study will contribute towards a PhD thesis, and likely other publications such as journal articles.

  • REC name

    North of Scotland Research Ethics Committee 2

  • REC reference

    18/NS/0115

  • Date of REC Opinion

    11 Oct 2018

  • REC opinion

    Favourable Opinion