The Innate Immune System and Inflammatory Bowel Disease | NCT00516776

Studies
The Innate Immune System and Inflammatory Bowel Disease

NCT00516776

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Feb 14, 2018Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Ulcerative Colitis
Crohn's Disease

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Aug 14, 2007

First Submission Date that Met QC Criteria

Aug 14, 2007

First Posted Date

Aug 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2018

Last Update Posted Date

Feb 14, 2018Actual

Name	Class
The Royal Norwegian Ministry of Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Actual

Measure	Description	Time Frame
gene expression patterns in mucosal biopsies		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of ulcerative colitis
Presence of Crohn's disease
Healthy (no sign of inflammatory bowel disease)

Exclusion Criteria:

Anticoagulation
Cardiac valvular disease
Intravascular prosthesis
Coagulation disorders
Gastrointestinal malignancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from endoscopy unit and outpatients clinic with ulcerative colitis, Crohn's disease and healthy controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne K Sandvik, MD PhD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Cancer Research and Molecular Medicine, NTNU		Trondheim		NO-7489	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25979109	Derived	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.
24739633	Derived

ID	Term
D003093	Colitis, Ulcerative
D003424	Crohn Disease

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases