The Bacterial Secretome in IBD

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT04136587
• Lead Sponsor: Medical University of Graz

Brief Summary

Secreted bacterial effectors produced by the intestinal microbiota are in part responsible for the proinflammatory effect of the fecal content in inflammatory bowel disease (IBD) patients.

Detailed Description

Fecal colonic content will be collected by suction during routine colonoscopy. From the fecal content different fractions (containing soluble bacterial fractions and membrane bound bacterial fractions) will be processed. These bacterial fractions (also termed as bacterial secretome) will be tested for proinflammatory potential in tissue culture assays including epithelial colonic cell lines and dendritic/monocytic cell lines. The main outcome parameter will be the secretion of proinflammatory cytokines from the tissue culture.

For this purpose the investigators will test different groups of patients including patients with active/inactive Crohn's disease or ulcerative colitis, patients with other inflammatory conditions of the colon, patients with colorectal carcinoma and healthy controls undergoing colonoscopy.

Study Timeline

• Study First Submitted: 2019-05-10
• Study Start: 2019-06-01
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controls	One day	Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Secondary Outcome Measures

Name	Time	Method
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type	one day	Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity	One day	Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases	One day	Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria