No registrations found.
ID
Source
Brief title
Health condition
Inflammatory bowel disease; Crohn's disease and Ulcerative colitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- Frequency and gene expression profiles of IgA producing B-cells in active and inactive disease
- Differences in immune cell populations (frequency, phenotype, cytokine production, genetic, epigenetic and transcriptional alterations) and stromal cells in lymph nodes in IBD patients and controls
- Differences in immune cell populations, amongst other germinal center B cells and Tfh responses, in peripheral lymph nodes of patients with active and inactive IBD, with and without ADAs
Background summary
One of the biggest barriers to progress towards better treatments in inflammatory bowel disease (IBD) is 1) our lack of understanding of the disease etiology and 2) our lack of understanding the mechanisms involved in response or lack/loss of response to treatments, such as the development of anti-drug antibodies. The gut associated lymphoid tissue (GALT) as well as peripheral lymph nodes (LN) are lymphoid structures that play an important role in and antibody formation and are involved in shaping intestinal and peripheral immunity. It is however unknown whether and how these lymphoid structures are involved in IBD etiology and whether they are involved in anti-drug antibody (ADA) formation. We hypothesize that 1) GALT and peripheral LN are involved in IBD pathophysiology, and 2) GALT and peripheral LN are involved in anti-drug antibody formation, and thereby loss of response to therapy.
Study objective
We hypothesize that 1) GALT and peripheral LN are involved in IBD pathophysiology, and 2) GALT and peripheral LN are involved in anti-drug antibody formation, and thereby loss of response to therapy.
Study design
1 time point only, baseline
Intervention
participating IBD patients and controls will undergo inguinal lymph node biopsy sampling and blood sampling. In addition, in a subgroup of IBD patients requiring gastro-intestinal surgery with bowel resection, mesenteric lymph nodes will be obtained as well as Peyer’s patches, which will be collected from the resected intestinal segment. In addition, in the patients undergoing cholecystectomy mesenteric lymph nodes will be collected.
Inclusion criteria
Inclusion criteria IBD patients:
- Age 18-80 years
- Additional for aim 1 (GALT tissue sampling): Patients with CD undergoing ileocecal resection because of (inflammatory or fibrotic) stenosis or extensive inflammation or therapy refractory disease
Inclusion criteria healthy controls (Aim 1)
- Patients undergoing cholecystectomy in the non-acute setting (symptomatic gall stone disease), without active inflammation
- Negative for inflammatory bowel pathologies. - Age 18-80 years.
Exclusion criteria
Exclusion criteria 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 enrollment
- For aim 1: Present or previous use up to 3 months before enrolement of general immunosuppressive agents (e.g. Azathioprine, Methotrexate, Mycophenolate Mofetil) or biological treatments
Exclusion criteria control patients (undergoing cholecystectomy (Aim 1):
- Presence of intestinal inflammatory conditions (e.g. active cholecystitis)
- Presence of inflammatory bowel disease
- 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
NL76643.018.21 / Immunotyping lymph nodes in IBD
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- History of autoimmune disease
- History of malignancy
- Individuals, who are not able to provide informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9591 |
| Other | METC AMC : METC 2021_039 |