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Thursday, February 15th, 2018
Table of Contents

1 Introduction
5 PMID
 [F] Diseases Research  / PubMed Research Articles  /
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.

PubMed

 

Resource

BMJ open 02 ; 8(2)

Authors

Christensen R1; Heitmann BL2; Andersen KW3; Nielsen OH4; Sørensen SB5; Jawhara M6; Bygum A7; Hvid L8; Grauslund J9; Wied J10; Glerup H11; Fredberg U12; Villadsen JA13; Kjær SG14; Fallingborg J15; Moghadd SAGR16; Knudsen T17; Brodersen J18; Frøjk J19; Dahlerup JF20; Bojesen AB21; Sorensen GL22; Thiel S23; Færgeman NJ24; Brandslund I25; Bennike TB26; Stensballe A27; Schmidt EB28; Franke A29; Ellinghaus D30; Rosenstiel P31; Raes J32; Boye M33; Werner L34; Nielsen CL35; Munk HL36; Nexøe AB37; Ellingsen T38; Holmskov U39; Kjeldsen J40; Andersen V41;

Author Information
  • 1Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.
  • 2Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Denmark.
  • 3Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.
  • 4Department of Gastroenterology D112, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
  • 5Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.
  • 6Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.
  • 7Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark.
  • 8Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark.
  • 9Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
  • 10Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
  • 11Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 12Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 13Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 14Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 15Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark.
  • 16Department of Internal Medicine, Herning Regional Hospital, Herning, Denmark.
  • 17Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • 18Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • 19Department of Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark.
  • 20Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
  • 21Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.
  • 22Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark.
  • 23Department of Biomedicine, Aarhus University, Aarhus, Denmark.
  • 24Department of Biochemistry and Molecular Biology, Villum Center for Bioanalytical Sciences, University of Southern Denmark, Odense, Denmark.
  • 25institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • 26Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
  • 27Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
  • 28Department of Cardiology, Aalborg University Hospital, Ålborg, Denmark.
  • 29Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.
  • 30Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.
  • 31Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.
  • 32Departmentof Microbiology and Immunology, Rega Institute, KU Leuven-University of Leuven, Leuven, Belgium.
  • 33Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.
  • 34The Danish Psoriasis Association, The Danish Psoriasis Association, Tåstrup, Denmark.
  • 35The Danish Colitis-Crohn Association, The Danish Colitis-Crohn Association, Odense, Denmark.
  • 36Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 37Department of Gastroenterology, Odense University Hospital, Odense, Denmark.
  • 38Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.
  • 39Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark.
  • 40Department of Gastroenterology, Odense University Hospital, Odense, Denmark.
  • 41Focused Research Unit for Molecular Diagnostic and Clinical Research, IRS-Center Sonderjylland, Hospital of Southern Jutland, Aabenraa, Denmark.

Abstract

INTRODUCTION: Chronic 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 ANALYSIS: This 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 DISSEMINATION: The 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 NUMBER: NCT03173144; Pre-results.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PMID

29439003

Others

Publication Type: Journal Article, Research Support, Non-U.S. Gov't


This article is licensed under the the National Library of Medicine License. It uses material from the PubMed National Library of Medicine Data.


Last Modified:   2016-03-27


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