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
Christensen R, Heitmann BL, Andersen KW, Nielsen OH, Sørensen SB, Jawhara M, Bygum A, Hvid L, Grauslund J, Wied J, Glerup H, Fredberg U, Villadsen JA, Kjær SG, Fallingborg J, Moghadd SAGR, Knudsen T, Brodersen J, Frøjk J, Dahlerup JF, Bojesen AB, Sorensen GL, Thiel S, Færgeman NJ, Brandslund I, Bennike TB, Stensballe A, Schmidt EB, Franke A, Ellinghaus D, Rosenstiel P, Raes J, Boye M, Werner L, Nielsen CL, Munk HL, Nexøe AB, Ellingsen T, Holmskov U, Kjeldsen J, Andersen V
BMJ open · 21 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Estudio de cohortes (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Region Syddanmark
- Organización sin fines de lucro
- Oak Foundation
- Organización sin fines de lucro
- Villum Fonden
- Organización sin fines de lucro
- Parker Institute for Cancer Immunotherapy
- Gobierno
- European Commission
- Universidad u hospital
- Syddansk Universitet
- Organización sin fines de lucro
- Knud og Edith Eriksens Mindefond
- Gobierno
- H2020 European Research Council
- Universidad u hospital
- Odense Patient data Explorative Network
- Gobierno
- European Research Council
- Gobierno
- Region of Southern Denmark
- Subvenciones
- European Commission (733100); Villum Fonden (00007292)
Según 11 financiadores declarados.
Publicación
- Publicado
- 2018-02-01 · BMJ Open · vol. 8 · número 2 · pág. e018166
- Editorial
- BMJ
- Citado
- 24 citas · más que el 88% de estudios similares · 2.3× el promedio de su campo
- Referencias
- 125 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Inflammatory Bowel Disease · Hidradenitis Suppurativa and Treatments · Microscopic Colitis
- Palabras clave
- Medicine, Psoriatic arthritis, Prospective cohort study, Internal medicine, Psoriasis, Inflammatory bowel disease, Rheumatoid arthritis, Ulcerative colitis, Disease, Physical therapy, Cohort, Cohort study, Immunology
- MeSH
- humans, rheumatic diseases, inflammatory bowel diseases, uveitis, skin diseases, chronic disease, inflammation, tumor necrosis factor-alpha, prognosis, diet, prospective studies, life style, research design, quality of life, dietary fiber, meat products, precision medicine, red meat, patient reported outcome measures
41 autores
- Robin Christensen🇩🇰Frederiksberg Hospital
- Berit L. Heitmann🇩🇰University of Copenhagen; University of Southern Denmark; Frederiksberg Hospital
- Karina Winther Andersen🇩🇰Sygehus Sønderjylland
- Ole Haagen Nielsen🇩🇰University of Copenhagen; Herlev Hospital
- Signe Bek Sørensen🇩🇰University of Southern Denmark; Sygehus Sønderjylland
- Mohamad Jawhara🇩🇰University of Southern Denmark; Sygehus Sønderjylland
- Anette Bygum🇩🇰Odense University Hospital
- Lone Hvid🇩🇰Odense University Hospital
- Jakob Grauslund🇩🇰University of Southern Denmark; Odense University Hospital
- Jimmi Wied🇩🇰University of Southern Denmark; Odense University Hospital
- Henning Glerup🇩🇰Regionshospitalet Silkeborg
- Ulrich Fredberg🇩🇰Odense University Hospital; Regionshospitalet Silkeborg
- Jan Alexander Villadsen🇩🇰Regionshospitalet Silkeborg
- Søren Geill Kjær🇩🇰Regionshospitalet Silkeborg
- Jan Fallingborg🇩🇰Aalborg University Hospital
- Seyed A G R Moghadd🇩🇰Regionshospitalet Herning
- Torben Knudsen🇩🇰Hospital South West Jutland
- Jacob Broder Brodersen🇩🇰Hospital South West Jutland
- Jesper Frøjk🇩🇰Hospital South West Jutland
- Jens Frederik Dahlerup🇩🇰Aarhus University Hospital
- Anders Bo Bojesen🇩🇰Sygehus Sønderjylland
- Grith Lykke Sørensen🇩🇰University of Southern Denmark
- Steffen Thiel🇩🇰Aarhus University
- Nils Joakim Færgeman🇩🇰University of Southern Denmark
- Ivan Brandslund🇩🇰University of Southern Denmark; Lillebaelt Hospital
- Tue Bjerg Bennike🇩🇰Aalborg University
- Allan Stensballe🇩🇰Aalborg University
- Erik Berg Schmidt🇩🇰Aalborg University Hospital; Aalborg University
- André Franke🇩🇪Christian-Albrechts-Universität zu Kiel
- David Ellinghaus🇩🇪Christian-Albrechts-Universität zu Kiel
- Philip C Rosenstiel🇩🇪Christian-Albrechts-Universität zu Kiel
- Jeroen Raes🇧🇪Rega Institute for Medical Research; VIB-KU Leuven Center for Cancer Biology; KU Leuven
- Mette Boyé🇩🇰Sygehus Sønderjylland
- Lars Werner
- Charlotte Lindgaard Nielsen🇩🇰🇬🇧Danish Diabetes Association; Crohn's and Colitis UK
- Heidi Lausten Munk🇩🇰Odense University Hospital; Regionshospitalet Silkeborg
- Anders Bathum Nexøe🇩🇰 · autor de correspondenciaOdense University Hospital
- Torkell Ellingsen🇩🇰Odense University Hospital; Regionshospitalet Silkeborg
- Uffe Holmskov🇩🇰University of Southern Denmark
- Jens Kjeldsen🇩🇰Odense University Hospital
- Vibeke Charlotte Andersen🇩🇰 · autor de correspondenciaUniversity of Southern Denmark; Sygehus Sønderjylland
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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