The Bacterial Secretome in IBD

NCT ID: NCT04136587

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2024-07-31

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Controls

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

Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Intervention Type: OTHER

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)

Crohn's disease

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

Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Intervention Type: OTHER

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)

Ulcerative Colitis

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

Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Intervention Type: OTHER

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)

Colorectal carcinoma

Inclusion criteria:

• Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology

Exclusion criteria:

• None

Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Intervention Type: OTHER

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)

Colitis/Enteritis of other origin

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

Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Intervention Type: OTHER

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)

Interventions

Colonic 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Colonoscopy indicated by routine clinical care
• Established diagnosis of Crohn´s disease (also if established by the study colonoscopy)

• Colonoscopy indicated by routine clinical care
• Established diagnosis of ulcerative colitis (also if established by the study colonoscopy)

• Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology

• 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

• 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)

• 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)

• 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

• None

Group 5 (Colitis/Enteritis of different origin): n= 20

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Hoegenauer, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

17-199 ex 05/06

Identifier Type: -

Identifier Source: org_study_id