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The Bacterial Secretome in IBD

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Colonic fluid collection during endoscopy for analysis of the bacterial secretome
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Healthy Controls

Crohn's disease

Ulcerative Colitis

Colorectal carcinoma

Colitis/Enteritis of other origin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity
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 type
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
Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Full Information

First Posted
May 10, 2019
Last Updated
July 3, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04136587
Brief Title
The Bacterial Secretome in IBD
Official Title
The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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
Arm Title
Crohn's disease
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ulcerative Colitis
Arm Type
Active Comparator
Arm Description
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
Arm Title
Colorectal carcinoma
Arm Type
Active Comparator
Arm Description
Inclusion criteria: • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology Exclusion criteria: • None
Arm Title
Colitis/Enteritis of other origin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Colonic fluid collection during endoscopy for analysis of the bacterial secretome
Intervention Description
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)
Primary Outcome Measure Information:
Title
Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controls
Description
Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Time Frame
One day
Secondary Outcome Measure Information:
Title
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity
Description
Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Time Frame
One day
Title
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type
Description
Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Time Frame
one day
Title
Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases
Description
Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Hoegenauer, Prof
Phone
004331638581786
Email
christoph.hoegenauer@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Blesl, Dr
Phone
004331638580989
Email
andreas.blesl@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Hoegenauer, Prof
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Bacterial Secretome in IBD

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