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Stavanger University Hospital Inflammatory Bowel Disease Trial (SUSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01551563
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:

The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.

Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.

Condition or disease

Detailed Description:
none considered needed

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue
Study Start Date : April 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Primary Outcome Measures :
  1. Clinical efficacy of IBD drug therapy [ Time Frame: 5 years ]
    Endoscopic, clinical and biochemical response

Secondary Outcome Measures :
  1. Fatigue in patients with coeliac disease - substudy [ Time Frame: 1 year ]
    Fatigue at diagnosis and after one year of gluten free diet

  2. Fatigue in IBD [ Time Frame: 5 years ]
    Fatigue at diagnosis and during follow-up

Biospecimen Retention:   Samples With DNA
Plasma and mucosal biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area

Inclusion Criteria:

  • newly diagnosed IBD

Exclusion Criteria:

  • previous IBD with specific treatment within 10 year
  • inability to consent
  • inability to adhere to treatment protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551563

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Contact: tore grimstad
Contact: lars aabakken

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SUS Recruiting
Stavanger, Norway
Contact: Tore B Grimstad, MD PhD    +47909 21 650      
Sponsors and Collaborators
Helse Stavanger HF
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Principal Investigator: lars Aabakken prof of medicine UIO

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helse Stavanger HF Identifier: NCT01551563     History of Changes
Other Study ID Numbers: SUSI_1
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases