Stavanger University Hospital Inflammatory Bowel Disease Trial (SUSI)

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 28, 2014