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The Bacterial Secretome in IBD

The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04136587
Enrollment
74
Registered
2019-10-23
Start date
2019-06-01
Completion date
2024-07-31
Last updated
2025-03-26

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

Conditions

Inflammatory Bowel Diseases

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.

Interventions

OTHERColonic fluid collection during endoscopy for analysis of the bacterial secretome

Colonic content will be collected by suction during routine colonoscopy including the residual fluid in the colon and stool contents and also suction of washing fluid (sterile physiologic H2O solution)

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Group 1 (healthy controls): n=20 Inclusion criteria: * Colonoscopy performed for the following indications: anemia, blood in stool, constipation, change in bowel habits, screening for colon cancer, follow up after polyps, weight loss * Macroscopic normal colonoscopy except for diverticulosis (without any signs of inflammation), ≤ 3 polyps (except hyperplastic polyps of the colon and rectum), angiodysplasia

Exclusion criteria

* Diagnosis of IBD or any other inflammatory condition of the small and large intestine * Diagnosis of IBS * Autoimmune disorders * Obesity (BMI\> 30) * Regular intake of NSAIDs (\> 2 tablets/ week), immunosuppressants * Intake of antibiotics within the last 3 months * Intestinal infection by enteric pathogens * Probiotic therapy Group 2 (Crohn´s disease; CD): n= 20 (10 active CD; 10 inactive CD) Inclusion criteria: * Colonoscopy indicated by routine clinical care * Established diagnosis of Crohn´s disease (also if established by the study colonoscopy)

Design outcomes

Primary

MeasureTime frameDescription
Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controlsOne dayMeasurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Secondary

MeasureTime frameDescription
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activityOne dayMeasurement 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 typeone dayMeasurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseasesOne dayMeasurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026