Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in Inflammatory Bowel Disease (IBD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00915044
First received: June 3, 2009
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in IBD

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Migration towards chemokines,proliferation, cytokine secretion, phenotypical characterization. [ Time Frame: Once, when joining the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

15 ml peripheral blood will be obtained from all participants.


Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBD patients
Approximately 40 patients (adults and children) suffering from IBD will be enrolled.
Controls
Approximately 100 healthy controls

Detailed Description:

Background: Inflammatory bowel diseases, comprised of Crohn's Disease (CD) and ulcerative colitis (UC) are idiopathic disorders caused due to immunological, genetic, and environmental factors. These disorders are fairly common (in the US, there are 11 cases of CD and 7 cases of UC for every 100,000 people). The frequency of IBD, especially CD, are constantly rising (1). Clinical symptoms include diarrhea, rectal bleeding, abdominal pain, intestinal obstructions, and fistulas in CD. There are also systemic manifestations such as fever, weight loss, and anemia. The current hypothesis of IBD pathogenesis is an aberrant, ongoing, uncontrolled inflammatory response of the intestine, caused by commensal microbiota. The inflammatory response in IBD is mediated by T cells; in CD the pathologic lymphocytes are CD4 cells of Th1 type, while UC is considered an atypical Th2 response (2). CD4 T cells have a major role in initiation of inflammatory response in the gut, as well as a role in propagation and control of the inflammation.

Chemokines are low-molecular weight cytokines with chemoattractant capacity, and have a role in many inflammatory disorders. The chemokine CXCL12 is considered to be constitutively expressed (3). Our group found increased expression of CXCL12 in IBD (REF?). This finding suggests that CXCL12 might have a role in inflammatory processes of the gut.

Understanding phenotypical and functional differences of lymphocytes in mucosal homeostasis and IBD, elucidation of factors causing these differences, and recognition of causes for increased CXCL12 expression, will enable to increase knowledge of IBD; as well as lead to development of future therapeutic interventions in IBD.

Research Goals: To examine the effects of different environmental factors (cytokines, chemokines, extracellular matrix moieties) on immune cells from peripheral or intestinal source (in homeostasis or IBD) in terms of phenotypical and functional parameters.

Methods: 15 ml peripheral blood will be obtained from all participants. T lymphocytes will be isolated for the different experiments. Methods will include: Migration towards chemokines using the Transwell assay, proliferation will be assessed by either BrdU or thymidine incorporation, cytokine secretion will be determined using ELISA, phenotypical characterization will be done using flow cytometry and adhesion assays.

Ages: Adults and children aged 10-80. Research group: Approximately 40 patients (adults and children) suffering from IBD will be enrolled.

Control group: Approximately 100 controls will be enrolled in the research.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults and children aged 10-80. Research group: Approximately 40 patients (adults and children) suffering from IBD will be enrolled.

Control group: Approximately 100 controls will be enrolled in the research.

Criteria

Inclusion Criteria:

  • IBD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915044

Contacts
Contact: Iris Dotan, MD 972-3-6977305 irisd@tasmc.health.gov.il

Locations
Israel
Dep. of Gastroenterology, Tel Aviv medical center Recruiting
Tel Aviv, Israel
Contact: Iris Dotan, MD    972-3-6977305    Irisd@tasmc.health.gov.il   
Principal Investigator: Iris Dotan, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Iris Dotan, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Dr. Iris Dotan, Dep. of Gastroenterology, Tel Aviv medical center
ClinicalTrials.gov Identifier: NCT00915044     History of Changes
Other Study ID Numbers: TASMC-07-ID-153-CTIL, 153-07
Study First Received: June 3, 2009
Last Updated: June 4, 2009
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Tel-Aviv Sourasky Medical Center:
IBD

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014