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.
ID
Bron
Verkorte titel
Aandoening
Inflammatory bowel disease; Crohn's disease and Ulcerative colitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1 time point only, baseline
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Version number: 2.0 ,date: 07/04/2021 15 of 30
- History of autoimmune disease
- History of malignancy
- Individuals, who are not able to provide informed consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9591 |
| Ander register | METC AMC : METC 2021_039 |