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Uq0336c4b OA.Pdf DR NATASHA A KOLOSKI (Orcid ID : 0000-0002-8647-5933) PROFESSOR MARJORIE M WALKER (Orcid ID : 0000-0002-7788-0056) PROFESSOR G.J. HOLTMANN (Orcid ID : 0000-0002-0206-2358) Article type : Original Scientific Paper Submitted to: Alimentary Pharmacology & Therapeutics Date: 18 November 2018 -Revised 1 Population based study: Atopy and autoimmune diseases are associated with functional dyspepsia and irritable bowel syndrome, independent of psychological distress. Running title: Atopy, autoimmune disorders, functional dyspepsia and IBS Koloski Natasha,1-4 Jones Michael, 2,5 Walker Marjorie M,,1,2 Veysey Martin, 1 Zala Alkesh,6 Keely Simon, 1-2 Holtmann Gerald, 1,4 Talley Nicholas J 1,2, 6 1. Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia 2. Australian Gastrointestinal Research Alliance (AGIRA) 3. Department of Gastroenterology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia 4. School of Medicine, University of Queensland, St Lucia, QLD, Australia Author Manuscript 5. Macquarie University, Sydney, NSW, Australia. This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/apt.15120 This article is protected by copyright. All rights reserved 6. Department of Gastroenterology, John Hunter Hospital, New Lambton, NSW, Australia Correspondence and Reprints: Prof Nicholas Talley Faculty of Health & Medicine University of Newcastle Callaghan NSW 2305 Australia Email: [email protected] Grant Support This study was supported by a grant from Prometheus laboratories Specific author contributions: NAK was involved in study concept and design; acquisition of data; analysis and interpretation of data; critical revision of the manuscript for important intellectual content MJ was involved in study concept and design; analysis and interpretation of data; critical revision of the manuscript for important intellectual content; statistical analysis MMW was involved in study concept and design; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content. MV was involved in acquisition of data and critical revision of the manuscript for important intellectual content AZ was involved in acquisition of data and critical revision of the manuscript for important intellectual content SK was involved in study concept and design; critical revision of the manuscript for important intellectual content; statistical analysis. GH was involved with analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content. NJT was involved in study concept and design; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; study supervision. Author Manuscript Disclosures: This article is protected by copyright. All rights reserved NAK: None to disclose MPJ: Consultancies with GI Therapies (abdominal stimulation in constipation), SFI (prokinetics). MMW: Grant/Research Support: Prometheus Laboratories Inc [Irritable bowel syndrome (IBS Diagnostic), Commonwealth Diagnostics International (Biomarkers for FGIDs) MV: None to disclose AZ: None to disclose SK: Grant/Research Support: Cancer Institute NSW (Career Development Fellowship), National Health and Medical Research Council (Project Grant APP1128487) Commonwealth Diagnostics International (Biomarkers for FGIDs), Syntrix Biosystems (contract research - drug delivery). Consulting/Advisory Boards: Gossamer Bio, Aerpio Therapeutics GH: Unrestricted educational support from Bayer Ptd, Ltd and the Falk Foundation. Research support was provided via the Princess Alexandra Hospital, Brisbane by GI Therapies Pty Limited, Takeda Development Center Asia, Pty Ltd, Eli Lilly Australia Pty Limited, F.Hoffmann-La Roche Limited, MedImmune Ltd Celgene Pty Limited, Celgene International II Sarl, Gilead Sciences Pty Limited, Quintiles Pty Limited, Vital Food Processors Ltd, Datapharm Australia Pty Ltd Commonwealth Laboratories, Pty Limited, Prometheus Laboratories, Falk GmbH and Co Kg, Nestle Pty Ltd, Mylan. Patent Holder: A biopsy device to take aseptic biopsies (US 20150320407 A1) NJT: Grant/Research Support: Rome Foundation; Abbott Pharmaceuticals; Datapharm; Pfizer; Salix [Irritable bowel syndrome]; Prometheus Laboratories Inc [Irritable bowel syndrome (IBS Diagnostic)]; Janssen [Constipation]. Consultant/Advisory Boards: Adelphi Values [Functional dyspepsia (patient-reported outcome measures)]; (Budesonide)]; GI therapies [Chronic constipation (Rhythm IC)]; Allergens PLC; Napo Pharmaceutical; Outpost Medicine; Samsung Bioepis; Yuhan [IBS]; Synergy [IBS]; Theravance [Gastroparesis]. Patent Holder: Biomarkers of irritable bowel syndrome [Irritable bowel syndrome] Licensing Questionnaires [Mayo Clinic Talley Bowel Disease Questionnaire - Mayo Dysphagia Questionnaire]; Nestec European Patent [Application No. 12735358.9]; Singapore ‘Provisional’ Patent [NTU Ref: TD/129/17 “Microbiota Modulation Of BDNF Tissue Repair Pathway]. Summary Background: The pathogenesis of functional GI disorders (FGIDs) is uncertain. However, underlying immune activation and psychological distress has been documented in irritable bowel syndrome (IBS)Author Manuscript and functional dyspepsia (FD). Epidemiological data from the UK suggest FGIDs are linked to atopy and certain autoimmune diseases but this has not been confirmed. This article is protected by copyright. All rights reserved Aims: In a large population-based study we aimed to test if allergic or autoimmune diseases are independently associated with FGIDs, irrespective of psychological distress. Methods: A total of 3,542 people (mean age 57.9 years and 52.7% females) randomly selected from the Australian population, returned a mail survey (response rate = 43%). The survey asked about a physician diagnosis of autoimmune disease (scleroderma, psoriasis, rheumatoid arthritis and diabetes mellitus) or allergic conditions (asthma, food, pollen and/or animal allergy). The questionnaire assessed psychological distress and Rome III criteria for FD and IBS. Results: Asthma, food, pollen and animal allergies, psoriasis and rheumatoid arthritis were univariately significantly associated with IBS and FD. Food allergy (OR=1.66;95%CI 1.15- 2.40, P=0.007), psoriasis (OR=1.81;95%CI 1.19-2.74, P=0.006) and rheumatoid arthritis (OR=1.68;95%CI 1.15-2.4, P=0.007) were independent risk factors for IBS, controlling for age, sex and psychological distress. In FD, asthma (OR=1.32;95%CI 1.04-1.68, P=0.025) and food allergy (OR=1.78;95%CI 1.28-2.49, P=0.001) were independent predictors, controlling for age, sex and psychological distress. Conclusions: There is evidence that both atopic and autoimmune diseases are risk factors for FGIDs, independent of psychological distress, differing in IBS and FD. This provides evidence that different peripheral pathways may be involved in the pathogenesis of certain FGIDs. Keywords Functional gastrointestinal disorders; allergy; autoimmune disease; psychological distress Introduction Irritable bowel syndrome (IBS) and functional dyspepsia (FD) are the most common functional gastrointestinal disorders (FGIDs) affecting up to 20% of the general population.1 Treatment alleviates, but does not cure symptoms. 2 Recent research suggests that immune activation is likely a key player in the development of these disorders. 3-7 Evidence for innate immune activation in the mucosa in IBS and FD has been observed 6-7 but the prevalence of Author Manuscript immune activation in FGIDs is uncertain. An alternative approach examining the potential role of immune activation in FGIDs is to ascertain the prevalence of IBS and FD occurring alongside other conditions in the general population known to be associated with immune This article is protected by copyright. All rights reserved dysregulation. A study from the UK, which evaluated 23,471 patients from the General Practice Research Database, found evidence for increased prevalence of immune and autoimmune disorders and IBS and functional dyspepsia. 8-9 It was found that there was an increased probability of a diagnosis of functional dyspepsia in those with immune related disorders such as rheumatological autoimmune diseases including rheumatoid arthritis, seronegative arthritis, psoriatic arthritis and ankylosing spondylitis. 8 Autoimmune conditions such as rheumatoid arthritis and psoriasis have a predominant T-helper-1 and T-helper-17 type immune response. 10-11 An excessive T-helper-1 response has also been observed in some cases of IBS. 12 Most of these studies however have been patient based and it is unknown whether these and other autoimmune diseases such as psoriasis and scleroderma are also associated with a diagnosis of IBS and FD in the general population. By contrast, atopy is characterised by a predominant T-helper-2 type immune response. In atopy (including asthma, eczema rhinitis/hay fever) an underlying disordered T-helper-2 immune responses occurs 13 and this also may happen in a subset of FGIDs. 14 Data obtained from birth cohort studies and patient- based studies have suggested that atopy is associated with both IBS and FD. 9,13-21 However, the role of specific allergies in FGIDs is less clear. A reaction to wheat proteins
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