1. Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases:protocol for a prospective cohort study of prognostic factors and personalised medicine
- Author
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Mette Boye, Jimmi Wied, Andre Franke, Henning Glerup, Tue Bjerg Bennike, Jacob Broder Brodersen, Jakob Grauslund, Ivan Brandslund, Jan Fallingborg, Ulrich Fredberg, Robin Christensen, Nils J. Færgeman, Steffen Thiel, Mohamad Jawhara, Vibeke Andersen, Anders Bojesen, Anette Bygum, Jens Frederik Dahlerup, Grith Lykke Sørensen, Jesper Frøjk, Torkell Ellingsen, Erik Berg Schmidt, Lars Werner, Jan Alexander Villadsen, Ole Haagen Nielsen, Philip Rosenstiel, Berit L. Heitmann, Søren Geill Kjær, Signe Bek Sørensen, David Ellinghaus, Lone Hvid, Uffe Holmskov, Charlotte Lindgaard Nielsen, Heidi Lausten Munk, Jeroen Raes, Karina Winther Andersen, Torben Knudsen, Anders Bathum Nexøe, Jens Kjeldsen, Seyed A G R Moghadd, and Allan Stensballe
- Subjects
Dietary Fiber ,Disease ,Inflammatory bowel disease ,0302 clinical medicine ,lifestyle and chronic inflammatory disease ,Quality of life ,Protocol ,Hidradenitis suppurativa ,Prospective Studies ,030212 general & internal medicine ,Precision Medicine ,Prospective cohort study ,Research Support, Non-U.S. Gov't ,EUROPEAN PROSPECTIVE COHORT ,ANKYLOSING-SPONDYLITIS ,General Medicine ,biomarker and lifestyle ,personalized medicine ,Prognosis ,CROHNS-DISEASE ,Medical Management ,3. Good health ,Meat Products ,ULCERATIVE-COLITIS ,SHORT HEALTH SCALE ,Research Design ,SULFATE-REDUCING BACTERIA ,030211 gastroenterology & hepatology ,medicine.medical_specialty ,Skin Diseases ,Uveitis ,03 medical and health sciences ,Psoriatic arthritis ,patient related outcome measures ,Rheumatic Diseases ,Internal medicine ,Psoriasis ,medicine ,Journal Article ,Humans ,Patient Reported Outcome Measures ,BOWEL-DISEASE ,Life Style ,LONG-TERM INTAKE ,FOOD FREQUENCY QUESTIONNAIRE ,Inflammation ,Tumor Necrosis Factor-alpha ,business.industry ,Inflammatory Bowel Diseases ,medicine.disease ,Comorbidity ,Diet ,RHEUMATOID-ARTHRITIS ,Red Meat ,Chronic Disease ,Quality of Life ,treatment outcome ,western style diet ,business - Abstract
IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results.
- Published
- 2018
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