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

Williams, A-J; Paramsothy, R; Wu, N; Ghaly, S; Leach, S; Paramsothy, S; Corte, C; O'Brien, C; Burke, C; Wark, G; Samocha-Bonet, D; Lambert, K; Ahlenstiel, G; Wasinger, V; Dutt, S; Pavli, P; Grimm, M; Lemberg, D; Connor, S; Leong, R; Hold, G

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

Williams, A-J Paramsothy, R Wu, N Ghaly, S Leach, S Paramsothy, S Corte, C O'Brien, C Burke, C

Wark, G Samocha-Bonet, D Lambert, K Ahlenstiel, G Wasinger, V Dutt, S Pavli, P Grimm, M Lemberg, D Connor, S Leong, R Hold, G

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: BMJ Open, 2021, 11, (2), pp. e042493
Issue Date:: 2021-02-16

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Field	Value	Language
dc.contributor.author	Williams, A-J
dc.contributor.author	Paramsothy, R
dc.contributor.author	Wu, N
dc.contributor.author	Ghaly, S
dc.contributor.author	Leach, S
dc.contributor.author	Paramsothy, S
dc.contributor.author	Corte, C
dc.contributor.author	O'Brien, C
dc.contributor.author	Burke, C https://orcid.org/0000-0002-8917-0019
dc.contributor.author	Wark, G
dc.contributor.author	Samocha-Bonet, D
dc.contributor.author	Lambert, K
dc.contributor.author	Ahlenstiel, G
dc.contributor.author	Wasinger, V
dc.contributor.author	Dutt, S
dc.contributor.author	Pavli, P
dc.contributor.author	Grimm, M
dc.contributor.author	Lemberg, D
dc.contributor.author	Connor, S
dc.contributor.author	Leong, R
dc.contributor.author	Hold, G
dc.date.accessioned	2022-01-12T07:35:52Z
dc.date.available	2022-01-12T07:35:52Z
dc.date.issued	2021-02-16
dc.identifier.citation	BMJ Open, 2021, 11, (2), pp. e042493
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/153000
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2020-042493
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.mesh	Australia
dc.subject.mesh	Gastrointestinal Microbiome
dc.subject.mesh	Humans
dc.subject.mesh	Inflammatory Bowel Diseases
dc.subject.mesh	Microbiota
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Proteomics
dc.subject.mesh	Humans
dc.subject.mesh	Inflammatory Bowel Diseases
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Proteomics
dc.subject.mesh	Australia
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Microbiota
dc.subject.mesh	Gastrointestinal Microbiome
dc.title	Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study.
dc.type	Journal Article
utslib.citation.volume	11
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Science
pubs.organisational-group	/University of Technology Sydney/Faculty of Science/School of Life Sciences
utslib.copyright.status	open_access	*
dc.date.updated	2022-01-12T07:35:50Z
pubs.issue	2
pubs.publication-status	Published online
pubs.volume	11
utslib.citation.issue	2

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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