Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease (DYSCOLIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02726243|
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : October 25, 2017
|Condition or disease|
|Inflammatory Bowel Disease Colorectal Cancer|
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 :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
|IBD without CRC|
|IBD with CRC|
|IBD with dysplasia|
|non IBD without CRC|
|non IBD with CRC|
|IBD-PSC without CRC|
|IBD-PSC with CRC|
IBD-PSC with dysplasia or healthy subjects
IBD-PSC with dysplasia or healthy subjects for whom a colonoscopy is scheduled
- Composition of fecal microbiota by 16S sequencing [ Time Frame: Baseline ]Microbiota composition will be assessed using MiSeq technology
- Profile of fecal bile acids [ Time Frame: Baseline ]
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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726243
|Contact: Harry SOKOL, MD PhD||(0)1 49 29 31 71 ext +email@example.com|
|Gastroenterology Department of Saint Antoine Hospital||Recruiting|
|Paris, France, 75012|
|Contact: Harry SOKOL, MD, PhD (0)1 49 29 31 71 ext +33 firstname.lastname@example.org|
|Principal Investigator:||Harry SOKOL, MD PhD||APHP|