Inflammatory bowel disease-Crohn's disease-Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our first aim is to determine the involvement of GALT (Peyer*s patches, mesenteric lymph nodes) and peripheral lymph nodes in the immune deregulation that is observed in IBD. We have defined primary study parameters as: 1) Frequencies and phenotype of immune cell populations in GALT in active and inactive IBD 2) Differences in immune cell populations (frequency, phenotype, cytokine production, genetic, epigenetic and transcriptional alterations) and stromal cells in GALT compared to peripheral lymph nodes | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary study parameters for our first aim we have defined: 1) Frequency and gene expression profiles of immunoglobulin producing B-cells and plasma cells in active and inactive disease 2) Differences in immune cell populations (frequency, phenotype, cytokine production, genetic, epigenetic and transcriptional alterations) and stromal cells in in peripheral lymph nodes in IBD patients and healthy controls Our second aim is to understand the pathophysiological mechanisms in inguinal lymph nodes of IBD patients in the development of immunogenicity to therapeutic antibodies. For this aim the study parameter will be: 3) Differences in immune cell populations, amongst other germinal center B cells and T follicular helper cell responses, in peripheral lymph nodes of patients with active and inactive IBD, with and without anti-drug antibodies ( ADAs). | — |
Countries
Netherlands
Outcome results
None listed