Abstract

Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study

BMJ Open. 2021 Feb 16;11(2):e042493. doi: 10.1136/bmjopen-2020-042493.

Astrid-Jane Williams 1 2, Ramesh Paramsothy 3, Nan Wu 4, Simon Ghaly 5, Steven Leach 6, Sudarshan Paramsothy 7 8, Crispin Corte 9, Claire O'Brien 10, Catherine Burke 11, Gabrielle Wark 5, Dorit Samocha-Bonet 12, Kelly Lambert 13 14, Golo Ahlenstiel 15, Valerie Wasinger 16, Shoma Dutt 17, Paul Pavli 18, Michael Grimm 4, Daniel Lemberg 19, Susan Connor 1 20, Rupert Leong 21, Georgina Hold 22

 
     

Author information

  • 1Department of Gastroenterology, Liverpool Hospital, Liverpool, New South Wales, Australia.
  • 2Ingham Institute, Liverpool, New South Wales, Australia.
  • 3Department of Gastroenterology & Hepatology, Blacktown Hospital, Blacktown, New South Wales, Australia.
  • 4St George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
  • 5Gastroenterology, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
  • 6Westfield Research Laboratories, Sydney Children's Hospital Randwick, Randwick, New South Wales, Australia.
  • 7Macquarie University Faculty of Medicine and Health Sciences, Sydney, New South Wales, Australia.
  • 8Concord Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
  • 9AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
  • 10Faculty of Science and Technology, University of Canberra, Canberra, Australian Capital Territory, Australia.
  • 11School of Life Sciences, University of Technology Sydney, Sydney, New South Wales, Australia.
  • 12Diabetes Division, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.
  • 13Centre for Health Research Illawarra Shoalhaven Population, University of Wollongong Faculty of Business, Wollongong, New South Wales, Australia.
  • 14Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, Australia.
  • 15Blacktown & Mount Druitt Hospital, Blacktown, New South Wales, Australia.
  • 16Bioanalytical Mass Spectrometry Facility, University of New South Wales, Sydney, New South Wales, Australia.
  • 17Department of Gastroenterology, The Sydney Children's Hospitals Network Randwick and Westmead, Westmead, New South Wales, Australia.
  • 18Gastroenterology Unit, Canberra Hospital, Canberra, Australian Capital Territory, Australia.
  • 19Department of Gastroenterology, Sydney Children's Hospital Randwick, Randwick, New South Wales, Australia.
  • 20South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
  • 21Gastroenterology and Liver Services, Concord Repatriation General Hospital, Concord, New South Wales, Australia.
  • 22Microbiome Research Centre, University of New South Wales, Sydney, New South Wales, Australia georgina.hold@unsw.edu.au.

Abstract

Introduction: Crohn's disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia's first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.

Methods: The AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.

Ethics and dissemination: Ethical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.

Trial registration number: ACTRN12619000911190.

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