Ulcerative ColitisNCT00516776
The Innate Immune System and Inflammatory Bowel Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2007to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from endoscopy unit and outpatients clinic with ulcerative colitis, Crohn's disease and healthy controls
Who may be able to join
- Presence of ulcerative colitis
- Presence of Crohn's disease
- Healthy (no sign of inflammatory bowel disease)
Who cannot join
- Anticoagulation
- Cardiac valvular disease
- Intravascular prosthesis
- Coagulation disorders
- Gastrointestinal malignancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept of Cancer Research and Molecular Medicine, NTNU
Trondheim, NO-7489
About this study
The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls.
The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression patterns in mucosal biopsies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Arne K Sandvik, MD PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516776
- Sponsor's protocol ID
- 5.2007.910
- Status last verified
- Feb 2018
- First submitted
- 14 Aug 2007
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brenna O, Bruland T, Furnes MW, Granlund Av, Drozdov I, Emgard J, Bronstad G, Kidd M, Sandvik AK, Gustafsson BI. The guanylate cyclase-C signaling pathway is down-regulated in inflammatory bowel disease. Scand J Gastroenterol. 2015;50(10):1241-52. doi: 10.3109/00365521.2015.1038849. Epub 2015 May 15.
PubMed 25979109Ostvik AE, Granlund Av, Gustafsson BI, Torp SH, Espevik T, Mollnes TE, Damas JK, Sandvik AK. Mucosal toll-like receptor 3-dependent synthesis of complement factor B and systemic complement activation in inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jun;20(6):995-1003. doi: 10.1097/MIB.0000000000000035.
PubMed 24739633Ostvik AE, Granlund AV, Bugge M, Nilsen NJ, Torp SH, Waldum HL, Damas JK, Espevik T, Sandvik AK. Enhanced expression of CXCL10 in inflammatory bowel disease: potential role of mucosal Toll-like receptor 3 stimulation. Inflamm Bowel Dis. 2013 Feb;19(2):265-74. doi: 10.1002/ibd.23034.
PubMed 22685032
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Innate Immune System and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00516776
- Acronym / sponsor ID
- 5.2007.910
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Jun 2007 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls.
The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from endoscopy unit and outpatients clinic with ulcerative colitis, Crohn's disease and healthy controls
Key inclusion criteria (3 listed)
- Presence of ulcerative colitis
- Presence of Crohn's disease
- Healthy (no sign of inflammatory bowel disease)
Key exclusion criteria (5 listed)
- Anticoagulation
- Cardiac valvular disease
- Intravascular prosthesis
- Coagulation disorders
- Gastrointestinal malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gene expression patterns in mucosal biopsies
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Derived from this study: PubMed 25979109Brenna O, Bruland T, Furnes MW, Granlund Av, Drozdov I, Emgard J, Bronstad G, Kidd M, Sandvik AK, Gustafsson BI. The guanylate cyclase-C signaling pathway is down-regulated in inflammatory bowel disease. Scand J Gastroenterol. 2015;50(10):1241-52. doi: 10.3109/00365521.2015.1038849. Epub 2015 May 15.
- Derived from this study: PubMed 24739633Ostvik AE, Granlund Av, Gustafsson BI, Torp SH, Espevik T, Mollnes TE, Damas JK, Sandvik AK. Mucosal toll-like receptor 3-dependent synthesis of complement factor B and systemic complement activation in inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jun;20(6):995-1003. doi: 10.1097/MIB.0000000000000035.
- Derived from this study: PubMed 22685032Ostvik AE, Granlund AV, Bugge M, Nilsen NJ, Torp SH, Waldum HL, Damas JK, Espevik T, Sandvik AK. Enhanced expression of CXCL10 in inflammatory bowel disease: potential role of mucosal Toll-like receptor 3 stimulation. Inflamm Bowel Dis. 2013 Feb;19(2):265-74. doi: 10.1002/ibd.23034.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne K Sandvik, MD PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression patterns in mucosal biopsies (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516776, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.