Stavanger University Hospital Inflammatory Bowel Disease Trial

Recruiting

• Conditions: IBD

• Registration Number: NCT01551563
• Lead Sponsor: Helse Stavanger HF

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.

Detailed Description

none considered needed

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-12
• Study Start: 2012-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical efficacy of IBD drug therapy	5 years	Endoscopic, clinical and biochemical response

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SUS; 🇳🇴 Stavanger, Norway