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RecruitingNCT01551563SUSIUpdated May 16, 2025

Stavanger University Hospital Inflammatory Bowel Disease Trial

An observational study in IBD, sponsored by Helse Stavanger HF. Recruiting at 1 site in Norway. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Helse Stavanger HF · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
16 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

none considered needed

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Conditions studied

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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's planned enrollment of 700 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
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

Inclusion criteria

  • newly diagnosed IBD

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Clinical efficacy of IBD drug therapy

    Endoscopic, clinical and biochemical response

    Time frame: 5 years

Secondary outcomes

  1. Fatigue in patients with coeliac disease - substudy

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

    Time frame: 1 year

  2. Fatigue in IBD

    Fatigue severity and prevalence at diagnosis and during follow-up

    Time frame: 5 years

  3. IBD and the intestinal microbiome

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

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • SUS
    Stavanger, Norway
    • Tore B Grimstad, MD PhD · Contact · +47909 21 650
    Recruiting
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References and documents

Publications

  • Grimstad T, Skoie IM, Doerner J, Isaksen K, Karlsen L, Aabakken L, Omdal R, Putterman C. TWEAK is not elevated in patients with newly diagnosed inflammatory bowel disease. Scand J Gastroenterol. 2017 Apr;52(4):420-424. doi: 10.1080/00365521.2016.1273382. Epub 2016 Dec 31. PubMed 28040992 ↗
  • Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19. PubMed 25994356 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01551563
Lead sponsor
Helse Stavanger HF
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Apr 2012
Primary completion
Dec 2026 (estimated)
Completion
Dec 2030 (estimated)
Last update
May 16, 2025

Study contacts

tore grimstad
Contact
tore.bjorn.grimstad@sus.no
lars aabakken
Contact
larsaa@medisin.uio.no
Tore Grimstad, PhD
principal investigator · Helse Stavanger HF

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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