Clinical trial NCT04136587: The Bacterial Secretome in IBD
Official title: The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls and active and inactive UC patients

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.

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

Primary outcomes:
measure: Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controls
timeFrame: One day
Secondary outcomes:
measure: Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity
timeFrame: One day
measure: Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type
timeFrame: one day
measure: Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases
timeFrame: One day
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Christoph Hoegenauer, Prof
role: PRINCIPAL_INVESTIGATOR
References: