- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726243
Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease (DYSCOLIC)
Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
Study Overview
Status
Conditions
Detailed Description
Inflammatory bowel disease (IBD) are chronic and relapsing disabling disease. Crohn's disease (CD) and Ulcerative colitis (UC) are the two main types of IBD.
Patients with IBD are at greater risk of intestinal infection including viral infections (including cytomegalovirus) and bacterial (especially Clostridium difficile). In the long term, patients with colonic involvement are at an increased risk of colorectal cancer (CRC). Moreover, it has been reported in several cohort studies that patients with primary sclerosing cholangitis (PSC) associated with IBD (PSC-IBD), have an even increased risk of CRC (about 10 to 20% at 10 years). Other studies also suggest that the microbiota has an impact on liver diseases. Conversely, cholestatic liver diseases (such as PSC) can influence the microbiota, notably through modification of the production of bile acids. Finally, the role of the gut microbiota in the development of the CRC in IBD has been well established in animal models. The pathophysiological mechanisms are not well understood but may involve an alteration of the balance between protective bacteria against harmful microbiota.
This study aims to investigate the link between gut microbiota, intestinal inflammation, colorectal cancer, bile acid and liver diseases and this, through the creation of a biological collection of fecal microbiota from fecal samples from 8 groups of subjects: (i) IBD without CCR (ii) IBD with CCR, (iii) IBD with dysplasia, (iv) non IBD without CCR, (v) non IBD with CCR, (vi) IBD-CSP without CCR, (vii ) IBD-CSP with CCR, (viii) IBD-CSP with dysplasia. In these patients, microbiota composition will be assessed by sequencing technology.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Harry SOKOL, MD PhD
- Phone Number: +33 (0)1 49 29 31 71
- Email: harry.sokol@aphp.fr
Study Locations
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Paris, France, 75012
- Gastroenterology Department of Saint Antoine Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with the capacity to give informed consent.
- Age ≥ 18 years.
- A patient with IBD (Crohn's disease or ulcerative colitis) or healthy subject having a screening colonoscopy scheduled.
- Diagnosis of pathologies in question established or confirmed in any of the services involved in the study and according to international diagnostic criteria (Consensus ECCO).
- Patient follow-up in one of the services involved in the study
Exclusion Criteria:
- trusteeship, guardianship or safeguard justice.
- Subject does not speak French.
- Subject unable to answer questions or to speak.
- Previous history of colonic resection
- Taking antibiotics within 8 weeks preceding the stool sample Temporary exclusion criterium)
- Taking a bowel preparation for colonoscopy within 6 weeks before the stool sample (temporary exclusion criterium). Sampling is possible before bowel preparation or on the first stool after starting the bowel preparation.
- Ostomy at the time of sampling
- Current treatment by radiotherapy, chemotherapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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IBD without CRC
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IBD with CRC
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IBD with dysplasia
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non IBD without CRC
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non IBD with CRC
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IBD-PSC without CRC
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IBD-PSC with CRC
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IBD-PSC with dysplasia or healthy subjects
IBD-PSC with dysplasia or healthy subjects for whom a colonoscopy is scheduled
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composition of fecal microbiota by 16S sequencing
Time Frame: Baseline
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Microbiota composition will be assessed using MiSeq technology
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of fecal bile acids
Time Frame: Baseline
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Characterize the profile of fecal bile acids of the patients included in the biological. collection. After extraction, the bile acid profile will be determined by LC-MS / MS (liquid chromatography coupled to tandem mass spectrometry). - Characterize some cultivable species of gut microbiota of patients included in the study by culture. Aerobic and anaerobic bacterial strains will be isolated from patients stools and stored for further characterization. |
Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Harry SOKOL, MD PhD, APHP
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI13006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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