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
Authors: Christensen Robin , Heitmann Berit L , Andersen Karina Winther , Nielsen Ole Haagen , Sørensen Signe Bek , Jawhara Mohamad , Bygum Anette , Hvid Lone , Grauslund Jakob , Wied Jimmi , Glerup Henning , Fredberg Ulrich , Villadsen Jan Alexander , Kjær Søren Geill , Fallingborg Jan , Moghadd Seyed A G R , Knudsen Torben , Brodersen Jacob , Frøjk Jesper , Dahlerup Jens Frederik , Bojesen Anders Bo , Sorensen Grith Lykke , Thiel Steffen , Færgeman Nils J , Brandslund Ivan , Bennike Tue Bjerg , Stensballe Allan , Schmidt Erik Berg , Franke Andre , Ellinghaus David , Rosenstiel Philip , Raes Jeroen , Boye Mette , Werner Lars , Nielsen Charlotte Lindgaard , Munk Heidi Lausten , Nexøe Anders Bathum , Ellingsen Torkell , Holmskov Uffe , Kjeldsen Jens , Andersen Vibeke 
Published: December 2018

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.