Characterization of Inflammatory Cell Subpopulations of the Gut Associated Lymphoid Tissue and Peripheral Lymph Nodes in Inflammatory Bowel Disease
- Conditions
- Inflammatory bowel disease-Crohn's disease-Ulcerative colitis10017969
- Registration Number
- NL-OMON51080
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion criteria inflammatory bowel disease patients:
- Age 18-80 years
- Additional for aim 1 of METC research protocol: Patients with Crohn's
disease undergoing ileocecal resection because of (inflammatory or fibrotic)
stenosis or extensive inflammation or therapy refractory disease
Inclusion criteria healthy controls
- Negative for inflammatory bowel pathologies.
- Age 18-80 years.
Exclusion criteria for inflammatory bowel disease (IBD) patients:
- Patients, who are not able to provide informed consent.
- History of malignancy
- Viral or bacterial infection within the past 4 weeks
- Patients using anticoagulant therapy
- Present or previous use of systemic corticosteroids less than 28 days before
enrolment
- Present or previous use of general immunosuppressive agents (e.g.
Azathioprine, Methotrexate, Mycophenolate Mofetil)
Exclusion criteria healthy controls:
- Presence of bowel complaints or other intestinal inflammatory conditions
(e.g. diverticulitis)
- Individuals using anticoagulant therapy
- Present or previous use of systemic glucocorticoids less than 28 days before
enrolment
- Present or previous use of experimental drugs
- Present or previous treatment with any cell depleting therapies, including
investigational agents
- Presence of any disease for which study subjects need chronic or intermittent
immunosuppressive therapy (e.g. prednisolone).
- History of chronic viral infection
- Recent (<1 week) bacterial or viral infection
- History of autoimmune disease
- History of malignancy
- Individuals, who are not able to provide informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our first aim is to determine the involvement of GALT (Peyer*s patches,<br /><br>mesenteric lymph nodes) and peripheral lymph nodes in the immune deregulation<br /><br>that is observed in IBD.<br /><br><br /><br>We have defined primary study parameters as:<br /><br>1) Frequencies and phenotype of immune cell populations in GALT in active and<br /><br>inactive IBD<br /><br>2) Differences in immune cell populations (frequency, phenotype, cytokine<br /><br>production, genetic, epigenetic and transcriptional alterations) and stromal<br /><br>cells in GALT compared to peripheral lymph nodes</p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary study parameters for our first aim we have defined:<br /><br>1) Frequency and gene expression profiles of immunoglobulin producing B-cells<br /><br>and plasma cells in active and inactive disease<br /><br>2) Differences in immune cell populations (frequency, phenotype, cytokine<br /><br>production, genetic, epigenetic and transcriptional alterations) and stromal<br /><br>cells in in peripheral lymph nodes in IBD patients and healthy controls<br /><br><br /><br>Our second aim is to understand the pathophysiological mechanisms in inguinal<br /><br>lymph nodes of IBD patients in the development of immunogenicity to therapeutic<br /><br>antibodies.<br /><br>For this aim the study parameter will be:<br /><br>3) Differences in immune cell populations, amongst other germinal center B<br /><br>cells and T follicular helper cell responses, in peripheral lymph nodes of<br /><br>patients with active and inactive IBD, with and without anti-drug antibodies (<br /><br>ADAs).</p><br>