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Completed

NCT Number: NCT01430039

Syndecan-1 a Surrogate Marker for IBD

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1

Other names: Syndecan-1

Blood sample - venous blood 10 ml.

Procedure

venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1

Other names: Syndecan-1

Primary outcomes

  1. Elevated serum syndecan-1 levels as a bio marker for IBD

    Time frame: one year

    elevated serum syndecan-1 levels in patients with IBD compared to control

Secondary outcomes

  1. Serum syndecan-1 levels and disease severity Crohn's

    Time frame: one year

    Relationship between clinical data CDAI in crohn's patients and serum syndecan-1 levels

  2. Serum syndecan-1 levels and disease severity ulcerative colitis

    Time frame: one year

    Relationship between clinical data UCAI ulcerative colitis patients and serum syndecan-1 levels

  3. Serum syndecan-1 levels and C reactive protein(CRP) Crohn's

    Time frame: one year

    Relationship between lab data CRP levels in crohn's patients and serum syndecan-1 levels

  4. Serum syndecan-1 levels and C reactive protein(CRP) ulcerative colitis

    Time frame: one year

    Relationship between serum CRP levels and serum syndecan-1 levels in patients with ulcerative colitis

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Syndecan-1 as a Surrogate Marker for Inflammatory Bowel Disease

Acronym: syndecan1

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2011
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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