Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Disease; Colorectal Cancer

• Registration Number: NCT02726243
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composition of fecal microbiota by 16S sequencing	Baseline	Microbiota composition will be assessed using MiSeq technology

Secondary Outcome Measures

Name	Time	Method
Profile of fecal bile acids	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.

Trial Locations

Locations (1)

Gastroenterology Department of Saint Antoine Hospital; 🇫🇷 Paris, France