Clinical trial NCT01430039: Syndecan-1 a Surrogate Marker for IBD
Official title: Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn's disease
ulcerative colitis
Syndecan-1
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal population, having no known inflammatory disease

Brief summary: Syndecan-1 is a protein on the surface intestinal cells. previous studies proved low levels of mucosal syndecan-1 levels on the surface of intestinal cells is patients with acute and chronic inflammation due to inflammatory bowel disease.

this protein might shed from cell surface to the serum. The investigators wish to prove that elevated serum levels of syndecan-1 may be predictive of disease presence, extent and severity, that buy taking a simple blood sample from patients diagnosed with inflammatory bowel disease and comparing to normal subjects and to other markers.

Detailed description: One of the main hypothesis for the etiology of Inflammatory bowel disease (IBD) is an inappropriate and ongoing activation of the mucosal immune system in response to the presence of normal luminal flora. This aberrant response is most likely facilitated by defects in both the barrier function and the mucosal immune system of the intestinal epithelium. Syndecans are a class proteoglycans that take part in both cell adhesion and growth factor binding. Of the four known syndecan core proteins, syndecan-1 (CD138) and one of the best studied of this group and is also the relevant to the this study as it is expressed on the basolateral surface of columnar epithelial cells of the colon. Syndecan-1 functions as an integral membrane protein that participates in cell proliferation, cell migration and cell matrix interactions in the GI tract. Evidence for a reduction of syndecan-1 expression in the regenerating epithelium that overlies inflamed tissue was reported in both acute and chronic inflammation. This protein that is lost from the inflamed mucosal membrane might shed to the serum. Elevated serum levels of syndecan-1 may be predictive of disease presence and extent.

Eligibility criteria: Inclusion Criteria:

* informed consent
* no other concurrent inflammatory disease
* formal diagnosis of inflammatory bowel disease i.e Crohn's disease, Ulcerative colitis

Exclusion Criteria:

* pregnancy
* fever at time of sample taking

Primary outcomes:
measure: Elevated serum syndecan-1 levels as a bio marker for IBD
timeFrame: one year
Secondary outcomes:
measure: Serum syndecan-1 levels and disease severity Crohn's
timeFrame: one year
measure: Serum syndecan-1 levels and disease severity ulcerative colitis
timeFrame: one year
measure: Serum syndecan-1 levels and C reactive protein(CRP) Crohn's
timeFrame: one year
measure: Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis
timeFrame: one year
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: resident
name: Assaf Stein, Md
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
citation: Gaffney PR, O'Leary JJ, Doyle CT, Gaffney A, Hogan J, Smew F, Annis P. Response to heparin in patients with ulcerative colitis. Lancet. 1991 Jan 26;337(8735):238-9. doi: 10.1016/0140-6736(91)92201-c. No abstract available.
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