Syndecan-1 a Surrogate Marker for IBD

NCT ID: NCT01430039

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Crohn's, ulcerative colitis

Patients with diagnosed with Crohn's disease or ulcerative colitis who agreed to participate in the study and singed informed consent and answered a Crohn's disease activity index questioner for Crohn's disease or the ulcerative colitis activity index questioner for ulcerative colitis.

Blood sample - venous blood 10 ml.

Intervention Type: PROCEDURE

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

No disease

Healthy subjects with no known inflammatory disease. For basal serum levels of syndecan 1

blood sample

Intervention Type: PROCEDURE

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

Interventions

blood sample

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

Intervention Type: PROCEDURE

Blood sample - venous blood 10 ml.

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

Intervention Type: PROCEDURE

Other Intervention Names

Syndecan-1; Syndecan-1

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assaf Stein, Md

Role: PRINCIPAL_INVESTIGATOR

resident

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

References

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Reference Type: BACKGROUND

PMID: 21310817 (View on PubMed)

Bartlett AH, Hayashida K, Park PW. Molecular and cellular mechanisms of syndecans in tissue injury and inflammation. Mol Cells. 2007 Oct 31;24(2):153-66.

Reference Type: BACKGROUND

PMID: 17978567 (View on PubMed)

Bode L, Salvestrini C, Park PW, Li JP, Esko JD, Yamaguchi Y, Murch S, Freeze HH. Heparan sulfate and syndecan-1 are essential in maintaining murine and human intestinal epithelial barrier function. J Clin Invest. 2008 Jan;118(1):229-38. doi: 10.1172/JCI32335.

Reference Type: BACKGROUND

PMID: 18064305 (View on PubMed)

Carey DJ. Syndecans: multifunctional cell-surface co-receptors. Biochem J. 1997 Oct 1;327 ( Pt 1)(Pt 1):1-16. doi: 10.1042/bj3270001.

Reference Type: BACKGROUND

PMID: 9355727 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10627439 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16873088 (View on PubMed)

Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.

Reference Type: BACKGROUND

PMID: 12665470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1670865 (View on PubMed)

Day RM, Mitchell TJ, Knight SC, Forbes A. Regulation of epithelial syndecan-1 expression by inflammatory cytokines. Cytokine. 2003 Mar 7;21(5):224-33. doi: 10.1016/s1043-4666(03)00091-7.

Reference Type: BACKGROUND

PMID: 12824007 (View on PubMed)

Day R, Ilyas M, Daszak P, Talbot I, Forbes A. Expression of syndecan-1 in inflammatory bowel disease and a possible mechanism of heparin therapy. Dig Dis Sci. 1999 Dec;44(12):2508-15. doi: 10.1023/a:1026647308089.

Reference Type: BACKGROUND

PMID: 10630505 (View on PubMed)

Other Identifiers

31.08.11

Identifier Type: REGISTRY

Identifier Source: secondary_id

03.09.11.01

Identifier Type: -

Identifier Source: org_study_id