The Bacterial Secretome in IBD
Inflammatory Bowel Diseases
About this trial
This is an interventional basic science trial for Inflammatory Bowel Diseases
Eligibility 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)
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
Sites / Locations
- Medical University of GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Healthy Controls
Crohn's disease
Ulcerative Colitis
Colorectal carcinoma
Colitis/Enteritis of other origin
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
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
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
Inclusion criteria: • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology Exclusion criteria: • None
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