Inflammatory Bowel DiseasesNCT04136587
The Bacterial Secretome in IBD
An observational study of Inflammatory Bowel Diseases, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Colonic fluid collection during endoscopy for analysis of the bacterial secretome
- Type of treatment
- Pill or oral medicine
- How many people
- 74 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2019to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and active and inactive UC patients
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- None
- Group 5 (Colitis/Enteritis of different origin): n= 20
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Colonic fluid collection during endoscopy for analysis of the bacterial secretome
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic fluid collection during endoscopy for analysis of the bacterial secretomeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day
Secondary outcomes (3)
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
Measured: One day
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
Measured: one day
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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Jun 2019
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Hoegenauer, Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136587
- Sponsor's protocol ID
- 17-199 ex 05/06
- Status last verified
- Mar 2025
- First submitted
- 10 May 2019
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bacterial Secretome in Crohn's Disease and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04136587
- Acronym / sponsor ID
- 17-199 ex 05/06
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretomeInclusion 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 |
| Crohn's disease | – | Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome2 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 |
| Ulcerative Colitis | – | Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretome2 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 |
| Colorectal carcinoma | – | Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretomeInclusion criteria: • Diagnosis of a lesion with suspicion for colorectal cancer during endoscopy which is confirmed later by histology Exclusion criteria: • None |
| Colitis/Enteritis of other origin | – | Other: Colonic fluid collection during endoscopy for analysis of the bacterial secretomeInclusion 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and active and inactive UC patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonic fluid collection during endoscopy for analysis of the bacterial secretomeColonic 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) | Other | Colitis/Enteritis of other origin, Colorectal carcinoma, Crohn's disease, Healthy Controls, Ulcerative Colitis |
Primary outcome
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
3 secondary outcomes
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease activity
Time frame: One day
Concentration of proinflammatory cytokines of bacterial fractions in relation to disease type
Time frame: one day
Concentration of proinflammatory cytokines of bacterial fractions in other colonic diseases
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hoegenauer, Prof principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of proinflammatory cytokines of bacterial fractions in IBD compared to healthy controls (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.