OPEN Research Support
head

Professor
Vibeke Andersen
Molecular Diagnostics & Clinical Research, Hospital of Southern Jutland, Aabenraa


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.08.2016  
Slut 31.07.2021  
 



Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases

Short summary

Chronic inflammatory diseases (CID) are frequently treated with biologic medications, specifically TNF inhibitors [TNFi]. These medications inhibit the pro-inflammatory molecule tumour necrosis factor (TNF)-alfa, 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.


Rationale

Chronic inflammatory diseases (CID) are a diverse set of immunologic diseases that include inflammatory bowel disease (IBD) (Crohn's disease [CD] and ulcerative colitis [UC]), rheumatic conditions (rheumatoid arthritis [RA], axial spondyloarthropathy [axSpA], psoriatic arthritis [PsA]), inflammatory skin diseases (psoriasis [PsO], hidradenitis suppurativa [HS]), and eye disease (non-infectious uveitis [NiU]). The pro-inflammatory cytokine tumour necrosis factor alfa (TNF) is recognised to play an important role in the aetiology of these diseases. Correspondingly, biological agents that inhibit TNF, also known as TNF inhibitors (TNFi), are an important component of treatment. However, a large number of patients do not benefit from TNFi treatment.

CIDs have a large and negative impact on both individual patients and at a community level as a consequence of health-related workplace productivity loss and health system expense, which is largely influenced by the high cost of providing biologic medications. CIDs are recurring, lifelong illnesses of potentially early onset that can substantially affect the life quality of patients and their families. In addition, they are prevalent diseases with IBD affecting 0.5% of the population in the Western world, and RA and PsO effecting respectively 0.3-1.0% and 1.5% of the global population. Furthermore, the disease burden, and hence health system burden, is predicted to rise dramatically due to population growth, ageing demographics and increasing disease incidence.

This prospective cohort study will enrol 320 CID patients who are prescribed a TNFi. Included among the CID patients will be patients with inflammatory bowel disease (CD and UC), rheumatic disorders (RA, axSpA, PsA), inflammatory skin diseases (PsO and HS) and NiU. At baseline (pre-treatment), 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 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 primary aim of this prospective cohort study is to investigate whether treatment outcomes in CID patients vary with dietary differences. The main hypothesis is that 'Diets high in fibre AND low in red and processed meat are associated with improved treatment outcomes.' Secondary aims are whether and to what extent lifestyle-associated biomarkers have prognostic value for differentiating responders from non-responders based on both disease-specific and generic treatment outcomes.


Description of the cohort

This prospective cohort study will enrol around 320 adult CID patients who are prescribed a TNFi treatment for the first time. We aim to recruit a minimum of 100 patients with IBD, 100 patients with RA and 120 patients with axSpA, PsA, PsO, HS and NiU. Furthermore, 500 controls; subjects referred to a colonoscopy, will be enrolled.  The patients will have two visits, one at baseline (pre-treatment) and a follow up 14-16 weeks later. The controls are only seen once. 

This multi-centre study reflects a collaboration between the following centres:

1) Department of Gastroenterology and Hepatology, Aalborg University Hospital

2) Department of Hepatology and Gastroenterology, Aarhus University Hospital

3) Diagnostic Centre, Silkeborg Regional Hospital

4) Department of Gastroenterology, Herlev Hospital

5) Organ Centre, Hospital of Southern Jutland

6) Department of Gastroenterology, Hospital of South West Jutland

7) Department of Medical Gastroenterology, Department of Rheumatology, Department of Dermatology and Allergy Centre, and Department of Ophthalmology, Odense University Hospital. 


Data and biological material

Biological material (blood (EDTA plasma and serum), urine, faeces, biopsies (bowl))

A validated questionnaire containing information regarding dietary and non-dietary lifestyle, disease activity and quality of life.

Clinical activity scores on the individual patient groups 


Collaborating researchers and departments

Department of Rheumatology, Odense University Hospital

  • Professor Torkell Ellingsen, Ph.D, MD
  • Heidi Lausten Munk, MD, Ph.D

Department of Gastroenterology, Odense University Hospital

  • Professor Jens Kjeldsen, MD, Ph.D
  • Anders Bathum Nexøe, MD, Ph.D-stud

Department of Ophthalmology, Odense University Hospital

  • Associated Professor Jimmi Wied, MD, Ph.D
  • Professor Jakob Grauslund, MD, PhD

Department of Dermatology and Allergy Center, Odense University Hospital

  • Professor Anette Bygum, MD, Ph.D
  • Lone Hvid, MD

Diagnostic Center, Silkeborg Regional Hospital  

  • Henning Glerup, MD, Ph.D
  • Professor Ulrich Fredberg, MD, Ph.D
  • Jan Alexander Villadsen, MD
  • Søren Geill Kjær, MD

Department of Gastroenterology and Hepatology,  Aalborg University Hospital

  • Jan Fallingborg, MD

Department of Gastroenterology, Hospital of Southwest Jutland

  • Torben Knudsen, MD
  • Jacob Brodersen, MD
  • Jesper Frøjk, MD

Department of Hepatology and Gastroenterology, Aarhus University Hospital

  • Associated Professor Jens F. Dahlerup, MD, Ph.D

Department of Gastroenterology D112, Herlev Hospital

  • Professor Ole Haagen Nielsen, MD, Ph.D 
  • Ebbe Langholz, MD, Ph.D
  • Fredrik Holmberg, MD
  • Jakob Hendel MD, Ph.D

Organ Center, Hospital of Southern Jutland

  • Mohamad Jawhara, MD, Ph.D. stud 

Focused research unit for Molecular Diagnostic and Clinical Research, IRS Center Sonderjylland, Hospital of Southern Jutland

  • Post Doc Signe Bek Sørensen, MSc ,Ph.D

Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen

  • Senior scientist Robin Christensen, Ph.D

Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany

  • Professor Andre Franke, Ph.D
  • Professor David Ellinghaus, Ph.D
  • Professor Philip Rosenstiel, MD, Ph.D

Institute of Molecular Medicine, University of Southern Denmark

  • Associated professor Grith Lykke Pedersen, Ph.D
  • Professor Uffe Holmskov, MD, Ph.D

Department of Biomedicine, Aarhus University, Aarhus

  • Professor Steffen Thiel, MSc, Ph.D

Department of Biochemistry and Molecular Biology, Villum Center for Bioanalytical Sciences, University of Southern Denmark, Odense

  • Professor Nils Færgeman, MSc, Ph.D

Department of Clinical Biochemistry, Lillebaelt Hospital, Vejle

  • Professor Ivan Brandslund, MD, Ph.D

Department of Cardiology, Aalborg University Hospital, Aalborg

  • Professor Erik Berg Schmidt, MD, Ph.D

Department of Health Science and Technology, Aalborg University, Aalborg

  • Associated Professor Allan Stensballe, MSc, Ph.D

Research Unit for Dietary Studies, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen

  • Professor Berit L. Heitmann, DMD, Ph.D

Publications associated with the project

A Proposal for a Study on Treatment Selection and Lifestyle Recommendations in Chronic Inflammatory Diseases: A Danish Multidisciplinary Collaboration on Prognostic Factors and Personalised Medicine, Andersen V1,2,3,4, Holmskov U5, Sørensen SB6, Jawhara M7, Andersen KW8, Bygum A9, Hvid L10, Grauslund J11,12, Wied J13,14, Glerup H15, Fredberg U16, Villadsen JA17, Kjær SG18, Fallingborg J19, Moghadd SAGR20, Knudsen T21, Brodersen J22, Frøjk J23, Dahlerup JF24, Nielsen OH25, Christensen R26, Bojesen AB27, Sorensen GL28, Thiel S29, Færgeman NJ30, Brandslund I31,32, Stensballe A33, Schmidt EB34, Franke A35, Ellinghaus D36, Rosenstiel P37, Raes J38,39, Heitmann B40,41, Boye M42, Nielsen CL43, Werner L44, Kjeldsen J45, Ellingsen T46., Nutrients. 2017 May 15;9(5). pii: E499. doi: 10.3390/nu9050499.