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Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease (DYSCOLIC)

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ClinicalTrials.gov Identifier: NCT02726243
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date March 29, 2016
First Posted Date April 1, 2016
Last Update Posted Date October 25, 2017
Study Start Date November 2014
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2016)
Composition of fecal microbiota by 16S sequencing [ Time Frame: Baseline ]
Microbiota composition will be assessed using MiSeq technology
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02726243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 31, 2016)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease
Official Title Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
Brief Summary Build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Stools
Sampling Method Non-Probability Sample
Study Population Subjects with or without an inflammatory bowel disease, for whom a colonoscopy is scheduled.
Condition
  • Inflammatory Bowel Disease
  • Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 31, 2016)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Harry SOKOL, MD PhD (0)1 49 29 31 71 ext +33 harry.sokol@aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02726243
Other Study ID Numbers NI13006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Harry SOKOL, MD PhD APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2017