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Characterization of Inflammatory Cell Subpopulations of Gut Associated Lymphoid Tissue and Peripheral Lymph Nodes in Inflammatory Bowel Disease

Immunotyping lymph nodes in IBD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27715
Enrollment
64
Registered
2021-07-07
Start date
2021-06-29
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

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 r

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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

Contacts

Public ContactMaarten Pruijt

Amsterdam UMC, location AMC

m.j.pruijt@amsterdamumc.nl0650091289

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)