Chronic inflammatory diseases (CID) are frequently treated with biologic medications, specifically TNF inhibitors ). These medications inhibit the pro-inflammatory molecule tumour necrosis factor (TNF)-α, 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 effect treatment outcomes.
The aim of this PhD project is to identify lifestyle factors and biomarkers that may help improving treatment outcome. Methods and analysis: This prospective cohort study will enrol 320 CID patients who are prescribed a TNFi between June 2017 and March 2021.
Included among the CID patients will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), and inflammatory skin diseases (psoriasis, hidradenitis suppurativa).
Patients will be investigated at baseline (pre-treatment) and 2, 6, and 14-16 weeks after treatment initiation. Clinical information include 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). Biological sample include blood, urine, faeces, intestinal biopsies.
For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. Investigated covariates are: diet, including meat and fibre intake, and selected inflammatory biomarkers.
Statistics: We will explore whether any of the covariates help the clinicians to predict who will respond to therapy by using logistic regression.
Ehics and dissemination: 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 details: ClinicalTrials.gov identifier: NCT03173144.
1. Christensen R, Heitmann BL, Andersen KW, et al. 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. BMJ Open. 2018;8(2):e018166.
2. Andersen V, Hansen AK, Heitmann AB. Potential Impact of Diet on Treatment Effect from Anti-TNF Drugs in Inflammatory Bowel Disease. Nutrients. 2017;9(3).
3. Andersen V, Holmskov U, Sorensen SB, et al. 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. Nutrients. 2017;9(5).
The research team
You will be attached to SHS/IMM experiencing both a hospital research and university research environment. You will member of a small, ambitious, research team with various backgrounds (molecular biology, doctor, nurse, health research). You will be in close contact with other Ph.D. students.
Signe Bek Sørensen, postdoc, email@example.com, +45 2938 5683 (study coordinator).
Vibeke Andersen, professor, Focused Research Unit for Molecular Diagnostics and Clinical Research, University Hospital of Southern Jutland, Åbenrå, Institute of Molecular Medicine (IMM), University of Southern Denmark (SDU), Odense +45 2115 7790, firstname.lastname@example.org (main supervisor),
Jens Kjeldsen, Professor, Medical Gastroenterological Department, Odense University Hospital,
Uffe Holmskov, Professor, IMM, SDU, email@example.com.
A student with interest for clinical study coordination/contact with patients/biomedical research is preferred.
Fluent Danish needed.
The PhD protocol is under review at SDU.
You will be involved in applying for the economy (1-year wage paid by a H2020 project (syscid.eu)).
The study will be performed at University Hospital of Southern Denmark (SHS), 6200 Aabenraa, in close contact with SDU/OUH.
Only applicants with at least one published work will be accepted as Ph.D. students.
SHS may offer help to find an apartment. A nearby private institution offers children care facilities 24/7.
Salary: The PhD programme will be carried out in accordance with Faculty regulations and the Danish Ministerial Order on the PhD Programme at the Universities (PhD order). The terms of employment as a salaried PhD Research Fellow are stated in the Agreement between the Ministry of Finance and the Danish Confederation of Professional Associations (AC).
Applications must include:
• At letter stating the interest, motivation and qualifications for the project (max. 2 pages)
• Detailed CV, including personal contact information and documentation for at least one published study
• Certified copy of diploma (Master’s degree in a relevant field)
Closing date is 25.2.2019, interview is planned to take place in Åbenrå or Odense at the 1.3.2019.
Additional information may be requested and the application process may include an interview before final decision is made.
Incomplete applications and applications received after the deadline will not be considered.
Successful candidates will be asked to send an application to the PhD Secretariat, Faculty of Health Sciences, to be enrolled as PhD students.
All interested and qualified persons are encouraged to apply, regardless of age, gender, religious affiliation or ethnic background.