Stavanger University Hospital Inflammatory Bowel Disease Trial (SUSI)

March 14, 2024 updated by: Helse Stavanger HF

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

none considered needed

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Stavanger, Norway
        • Recruiting
        • SUS
        • Contact:
          • Tore B Grimstad, MD PhD
          • Phone Number: +47909 21 650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

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

Description

Inclusion Criteria:

  • newly diagnosed IBD

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy of IBD drug therapy
Time Frame: 5 years
Endoscopic, clinical and biochemical response
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue in patients with coeliac disease - substudy
Time Frame: 1 year
Fatigue severity and prevalence at diagnosis and after one year of gluten free diet
1 year
Fatigue in IBD
Time Frame: 5 years
Fatigue severity and prevalence at diagnosis and during follow-up
5 years
IBD and the intestinal microbiome
Time Frame: 5 years
Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimated)

March 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUSI_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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