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SUSI: Stavanger University Hospital Inflammatory Bowel Disease Trial

Sponsor
Helse Stavanger HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT01551563
Collaborator
(none)
600
Enrollment
1
Location
188
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Detailed Description

    none considered needed

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 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 :
    Apr 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Clinical efficacy of IBD drug therapy [5 years]

      Endoscopic, clinical and biochemical response

    Secondary Outcome Measures

    1. Fatigue in patients with coeliac disease - substudy [1 year]

      Fatigue severity and prevalence at diagnosis and after one year of gluten free diet

    2. Fatigue in IBD [5 years]

      Fatigue severity and prevalence at diagnosis and during follow-up

    3. IBD and the intestinal microbiome [5 years]

      Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 SUS Stavanger Norway

    Sponsors and Collaborators

    • Helse Stavanger HF

    Investigators

    • Principal Investigator: Tore Grimstad, PhD, Helse Stavanger HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helse Stavanger HF
    ClinicalTrials.gov Identifier:
    NCT01551563
    Other Study ID Numbers:
    • SUSI_1
    First Posted:
    Mar 12, 2012
    Last Update Posted:
    Mar 1, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Mar 1, 2021