The Innate Immune Response and Enteric Nervous System in Crohn's Disease.

Terminated

• Conditions: Crohn Disease

• Registration Number: NCT06485193
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.

Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Status Verified: 2024-06
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.

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Exclusion Criteria

• If the tissue material does not include the ileocecal region.
• If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
• If the patient has registered a prohibition against research in the Tissue Utilization Registry.
• The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MxA expression	June 1 2024	Immunohistochemical Mxa expression

Secondary Outcome Measures

Name	Time	Method
Enterovirus positivity	June 1 2024	pan-enterovirus immunohistochemistry

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Northern Region, Denmark