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Completed

NCT Number: NCT04136587

The Bacterial Secretome in IBD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controls

    Time frame: One day

    Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Secondary outcomes

  1. Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity

    Time frame: One day

    Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

  2. Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type

    Time frame: one day

    Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

  3. Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases

    Time frame: One day

    Measurement of proinflammatory cytokines (f.e.: IL-8) in epithelial and dendritic tissue culture assays

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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