Status:
COMPLETED
The Bacterial Secretome in IBD
Lead Sponsor:
Medical University of Graz
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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)
- Exclusion criteria:
- • Intestinal infection by enteric pathogens
- Definition of active CD Harvey-Bradshaw Index - HBI ≥ 5 and / or Simple Endoscopic Score for Crohn Disease (SES-CD) ≥ 3
- Except SES-CD scores resulting from isolated lesions only located at the ileocolonic anastomosis consistent with a modified Rutgeerts score i2a (these patients are considered as endoscopically non active)
- Definition of inactive CD
- Harvey-Bradshaw Index (HBI) \< 5 and Simple Endoscopic Score for Crohn Disease (SES-CD) \< 3
- Except SES-CD scores resulting from isolated lesions only located at the ileocolonic anastomosis consistent with a modified Rutgeerts score i2a (these patients are considered as endoscopically non active)
- Group 3 (Ulcerative colitis, UC): n= 20 (10 active UC; 10 inactive UC)
- 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
- Definition of active UC Total Mayo score ≥ 3 and Endoscopic Mayo subscore ≥ 2
- Definition of inactive UC Total Mayo score \< 3 and Endoscopic Mayo subscore 0 or 1.
- Group 4 (Colorectal cancer): n= 10
- Inclusion criteria:
- • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology
- Exclusion criteria:
- • None
- Group 5 (Colitis/Enteritis of different origin): n= 20
- Inclusion criteria:
- Diagnosis of intestinal inflammation at endoscopy or histology
- E.g.: Infectious colitis /enteritis; ischemic Colitis; microscopic colitis; GVHD; NSAID colitis; Colitis of unknown cause
- Exclusion criteria:
- • None
Exclusion
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04136587
Start Date
June 1 2019
End Date
July 31 2024
Last Update
March 26 2025
Active Locations (1)
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1
Medical University of Graz
Graz, Austria