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.