NCT04136587Completed
The Bacterial Secretome in IBD
The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 74 (actual)
- First submitted
- 10 May 2019
- Start date
- 1 Jun 2019
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Medical University of Graz
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04136587
What you commit to
- Study type: Observational
- Participants enrolled: 74
- From 1 Jun 2019 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of IBD or any other inflammatory condition of the small and large intestine
- Autoimmune disorders
- 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
Other
- Diagnosis of IBS
- Obesity (BMI\> 30)
- Regular intake of NSAIDs (\> 2 tablets/ week), immunosuppressants
- Intake of antibiotics within the last 3 months
- None
- Group 5 (Colitis/Enteritis of different origin): n= 20
- None
Who the study is looking for
- 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
Criteria the registry did not label
- Group 1 (healthy controls): n=20
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.