Clinical trial NCT02726243: Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease
Official title: Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Colorectal Cancer
Keywords: Inflammatory bowel disease
Crohn's Disease
Ulcerative Colitis
colorectal cancer
primary sclerosing cholangitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-04-01
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with or without an inflammatory bowel disease, for whom a colonoscopy is scheduled.

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.

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

Primary outcomes:
measure: Composition of fecal microbiota by 16S sequencing
timeFrame: Baseline
Secondary outcomes:
measure: Profile of fecal bile acids
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Gastroenterology Department of Saint Antoine Hospital
Study officials:
affiliation: APHP
name: Harry SOKOL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavelle A, Nancey S, Reimund JM, Laharie D, Marteau P, Treton X, Allez M, Roblin X, Malamut G, Oeuvray C, Rolhion N, Dray X, Rainteau D, Lamaziere A, Gauliard E, Kirchgesner J, Beaugerie L, Seksik P, Peyrin-Biroulet L, Sokol H. Fecal microbiota and bile acids in IBD patients undergoing screening for colorectal cancer. Gut Microbes. 2022 Jan-Dec;14(1):2078620. doi: 10.1080/19490976.2022.2078620.