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NCT Number: NCT01551563

Stavanger University Hospital Inflammatory Bowel Disease Trial

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.

Recruiting

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Key information

Conditions

IBD

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SUS

Stavanger, Norway

Location status: Recruiting

Location contact

Tore B Grimstad, MD PhD

CONTACT

+47909 21 650

About this study

none considered needed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed IBD

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Clinical efficacy of IBD drug therapy

    Time frame: 5 years

    Endoscopic, clinical and biochemical response

Secondary outcomes

  1. 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

  2. Fatigue in IBD

    Time frame: 5 years

    Fatigue severity and prevalence at diagnosis and during follow-up

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

lars aabakken

CONTACT

[email protected]

tore grimstad

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study 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

Acronym: SUSI

Important dates

Study start
2012
Primary completion
2026
Study completion
2030
First posted
Mar 12, 2012
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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