Inflammatory Bowel DiseaseIBDNCT00915044
Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in Inflammatory Bowel Disease (IBD)
An observational study of Inflammatory Bowel Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2007to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- IBD
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dep. of Gastroenterology, Tel Aviv medical center
Tel Aviv
Iris Dotan, MD, 972-3-6977305, Irisd@tasmc.health.gov.il
Iris Dotan, MD
About this study
Official title: Characterization of Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in IBD
The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Approximately 40 patients (adults and children) suffering from IBD will be enrolled. | |
| Controls | Approximately 100 healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration towards chemokines,proliferation, cytokine secretion, phenotypical characterization.
Measured: Once, when joining the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Dotan, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915044
- Sponsor's protocol ID
- TASMC-07-ID-153-CTIL
- Other IDs
- 153-07
- Acronym
- IBD
- Status last verified
- Jun 2009
- First submitted
- 3 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in IBD
- ClinicalTrials.gov ID
- NCT00915044
- Acronym / sponsor ID
- IBD / TASMC-07-ID-153-CTIL
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2007
- Primary completion
- Jul 2014 (estimated)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of different environmental factors on immune cells in patients with IBD.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | –Approximately 40 patients (adults and children) suffering from IBD will be enrolled. |
| Controls | – | –Approximately 100 healthy controls |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- IBD
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Migration towards chemokines,proliferation, cytokine secretion, phenotypical characterization.
Time frame: Once, when joining the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Dotan, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Dotan, MD (972-3-6977305, irisd@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration towards chemokines,proliferation, cytokine secretion, phenotypical characterization. (time frame: Once, when joining the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2009.