The Bacterial Secretome in IBD
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ulcerative Colitis Colonic fluid collection during endoscopy for analysis of the bacterial secretome 2 Subgroups: inactive disease (10 patients) and active disease (10 patients) Inclusion criteria: * Colonoscopy indicated by routine clinical care * Established diagnosis of ulcerative colitis (also if established by the study colonoscopy) Exclusion criteria: • Intestinal infection by enteric pathogens Crohn's disease Colonic fluid collection during endoscopy for analysis of the bacterial secretome 2 Subgroups: inactive disease (10 patients) and active disease (10 patients) Inclusion criteria: * Colonoscopy indicated by routine clinical care * Established diagnosis of Crohn´s disease (also if established by the study colonoscopy) Exclusion criteria: • Intestinal infection by enteric pathogens Colorectal carcinoma Colonic fluid collection during endoscopy for analysis of the bacterial secretome Inclusion criteria: • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology Exclusion criteria: • None Colitis/Enteritis of other origin Colonic fluid collection during endoscopy for analysis of the bacterial secretome Inclusion criteria: * Diagnosis of intestinal inflammation at endoscopy or histology * E.g.: Infectious colitis /enteritis; ischemic Colitis; microscopic colitis; graft versus host disease (GVHD); NSAID colitis; Colitis of unknown cause Exclusion criteria: • None Healthy Controls Colonic fluid collection during endoscopy for analysis of the bacterial secretome 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 irritable bowel syndrome (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
- 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