Stavanger University Hospital Inflammatory Bowel Disease Trial (SUSI)

This study is currently recruiting participants.
Verified December 2013 by Helse Stavanger HF
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01551563
First received: March 8, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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
IBD

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Clinical efficacy of IBD drug therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Endoscopic, clinical and biochemical response


Biospecimen Retention:   Samples With DNA

Plasma and mucosal biopsies


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

none considered needed

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • newly diagnosed IBD

Exclusion Criteria:

  • previous IBD with specific treatment within 10 year
  • inability to consent
  • inability to adhere to treatment protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551563

Locations
Norway
SUS Recruiting
Stavanger, Norway
Contact: Tore B Grimstad, MD PhD    +47909 21 650      
Sponsors and Collaborators
Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01551563     History of Changes
Other Study ID Numbers: SUSI_1
Study First Received: March 8, 2012
Last Updated: December 4, 2013
Health Authority: Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on April 16, 2014