The Bacterial Secretome in IBD

NCT04136587 | Completed

• 1 other identifier: 17-199 ex 05/06
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  One day

Secondary Outcomes (3)

• Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity

  One day

• Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type

  one day

• Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases

  One day

Study Arms (5)

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

Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome

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

Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome

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

Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Colorectal carcinoma

Inclusion criteria: • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology Exclusion criteria: • None

Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome

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

Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome

Interventions

Colonic fluid collection during endoscopy for analysis of the bacterial secretome 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; Colorectal carcinoma; Crohn's disease; Healthy Controls; Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls and active and inactive UC patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic fluid

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christoph Hoegenauer, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: October 23, 2019
• Study Start: June 1, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)