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IBSEN III - Inflammatory Bowel Disease in South Eastern Norway

The IBSEN III study is a large population-based observational, prospective study designed to answer several important challenges within Inflammatory Bowel Disease (IBD)-treatment and care.

About the Project

Has IBD epidemiology changed over the last 20 years in Norway and what are the implications for the patients, the health care and social security systems?  Can we identify risk factors and predict disease course and response to different treatments? Can we find new targets for medication and better strategies for psychosocial care?

Patients with IBD constitute the largest group of chronically diseased patients within the field of gastroenterology. About 2.5-3 million Europeans are affected and the incidence has been increasing worldwide during the last decades, especially in the pediatric population.

Being diagnosed with IBD, the patients face the prospect of a lifelong medical condition with a heterogeneous, unpredictable and potentially debilitating disease course. Thus the total impact of IBD is considerable, both for the patient and the society. Therefore, early intervention and careful, individualized planning is essential.

Three overriding challenges within IBD treatment and care have generated the IBSEN III study protocol:

  1. Rapid and continuous changes in IBD epidemiology
  2. The lack of valid tools (including clinical, biomedical and patient-reported factors) to identify risk factors associated with the disease as well as prediction of disease course and response to treatment.
  3. The need for new targets for medication and better strategies for psychosocial care.

Objectives

Primary objective

The IBSEN III study aims to find and test diagnostic, prognostic and predictive factors for improved, personalized treatment and care for patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis).

Secondary objectives

  • To provide a detailed description of baseline characteristics and disease course during follow-up for  IBD patients as the basis for further prognostic research
  • To identify clinical, endoscopic and radiological characteristics that can predict disease outcome and treatment effect in IBD
  • To identify diagnostic, prognostic and predictive biomarkers (serological, microbial and immunological) in IBD
  • To identify psychosocial and socioeconomic factors that can predict disease outcome in IBD
  • To develop and validate prognostic and predictive models for IBD based on the above
  • To investigate the effect of the primary treatment on the course of disease with focus on biological treatment
  • To determine the incidence of Crohn’s disease  and ulcerative colitis in adults and pediatric patients in South-Eastern Norway
  • To investigate time trends in IBD incidence and the possible relationships between IBD incidence and environmental and socioeconomic factors
  • To estimate direct and indirect cost of IBD in Norway as a basis for the development of health economic models
  • To develop health economic models evaluating cost effectiveness of implementing different diagnostic, prognostic and predictive tools in IBD 
  • To assess psychosocial health, fatigue and HRQoL in IBD patients over time in order to identify risk and protective factors regarding mood disorders and other psychological symptoms related to IBD
  • To explore the role of nutrition in the etiology and disease course of IBD

Background

Large scale, unselected and treatment naïve study populations are optimal for the studies of etiology and prognostic factors, as well as changes in epidemiology and possible alterations of the natural disease course.

The IBSEN III study will map newly diagnosed and treatment naïve IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) to improve targeted and individualized treatment and care.

The study is an observational population-based inception cohort study with prospective follow-up after 1 and 5 years. It will include adults and pediatric patients with untreated and newly diagnosed IBD as well as non-IBD controls, recruited from a geographically well-defined area (the South Eastern Health Region) from 1.1.2017 to 31.12.2019. W

e will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces, urine and mucosal biopsies for biobanking.

Working groups

The study includes several sub-projects within six work groups:

  • Clinical epidemiology and health economy 
  • Diet and IBD
  • Radiology
  • Patient-reported outcomes
  • Pediatric IBD
  • Microbiota, immunology, genetics and epigenetics

Specific sub-projects

  • Changes in epidemiology and treatment regimens in inflammatory bowel disease – implications for the patient and the health service

  • Clinical impact of gut microbiota in diagnosis and follow-up of patients with inflammatory bowel disease
  • Symptoms and symptom clusters as a basis for a tailored intervention in patients with inflammatory bowel disease
  • Fatigue, dysbiosis and inflammation in inflammatory bowel disease
  • Artificial intelligence to improve quality of colonoscopy (AICRIM)
  • What did IBSEN eat? Diet in inflammatory bowel disease

Financing

The study has received non-restricted research grants from Takeda, Tillotts and Ferring Pharmaceuticals. 

Cooperation

The IBSEN III study group comprises a large network of gastroenterologists, pediatricians, radiologists and nurses from all hospital trusts in the South Eastern Health Region.

Additionally we cooperate with a large group of researchers outside and within UiO.

  • Unger-Vetlesens Institute at Lovisenberg Diaconal Hospital
  • PELIKANTRA: Pediatric Liver Kidney Alimentary Nutrition and Transplantation Research Group
  • Genomics and Metagenomics in Inflammatory Disorders (Hov Group), Norwegian PSC Research Center and Research Institute of Internal Medicine, UiO and OUS
  • NORSMAN: Network for research and Innovation to decrease Symptom Burden and Improve Quality of Life Outcomes in Patients with Chronic Conditions (OUH)
  • HEKS: Helsesvikt, epidemiologi, kronisk sykdom og symptomforskning (Østfold University College)
  • AICRIM endoscopy study group: Artificial intelligence to improve colonoscopy quality

Involved research groups at UiO

Project start and finish

Inclusion period 1.1.2017 to 31.12. 2019. The patients will be followed prospectively for five years.

Project leader

MD, PhD Marte Lie Høivik, Department of Gastroenterology, Oslo University Hospital

Steering committee and group leaders

Steering committee

  • Marte Lie Høivik, leader, OUH
  • Vendel A. Kristensen, OUH
  • Randi Opheim, UiO and OUH
  • Gøri Perminow, OUH  
  • Petr Ricanek, Ahus
  • Trond Espen Detlie, UiO and Ahus
  • Gert Huppertz Hauss, Telemark Hospital

Group leaders

  • Clinical epidemiology and health economy, Marte Lie Høivik, OUH
  • Diet and IBD, Anne-Marie Aas, UiO and OUH
  • Radiology, Anne Negård, UiO and Akershus University Hospital (Ahus)
  • Patient-reported outcomes, Randi Opheim, UiO and OUH
  • Pediatric IBD, Gøri Perminow, OUH
  • Microbiota, immunology, genetics and epigenetics, Petr Ricanek, Ahus

 

Published Feb. 12, 2018 11:43 AM - Last modified Sep. 18, 2018 2:15 PM

Contact

Project leader

 

Participants

Detailed list of participants