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

Recruiting

• Conditions: Inflammatory bowel disease; Crohn's disease and Ulcerative colitis

• Registration Number: NL-OMON27715
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 64

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
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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Frequencies and phenotype of immune cell populations in GALT in active and inactive IBD<br>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 Measures

Name	Time	Method
- Frequency and gene expression profiles of IgA producing B-cells in active and inactive disease<br>- 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<br>- 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