Inflammatory Bowel DiseaseDYSCOLICNCT02726243
Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Colorectal Cancer
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with or without an inflammatory bowel disease, for whom a colonoscopy is scheduled.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Gastroenterology Department of Saint Antoine Hospital
Paris, 75012
About this study
Official title: Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
Build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).
Read the 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.
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Keywords
- Inflammatory bowel disease, Crohn's Disease, Ulcerative Colitis, colorectal cancer, primary sclerosing cholangitis
- Medical subject headings
- Inflammatory Bowel Diseases, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD without CRC | Not described | |
| IBD with CRC | Not described | |
| IBD with dysplasia | Not described | |
| non IBD without CRC | Not described | |
| non IBD with CRC | Not described | |
| IBD-PSC without CRC | Not described | |
| IBD-PSC with CRC | Not described | |
| IBD-PSC with dysplasia or healthy subjects | IBD-PSC with dysplasia or healthy subjects for whom a colonoscopy is scheduled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of fecal microbiota by 16S sequencing
Microbiota composition will be assessed using MiSeq technology
Measured: Baseline
Secondary outcomes (1)
Profile of fecal bile acids
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startNov 2014
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry SOKOL, MD PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726243
- Sponsor's protocol ID
- NI13006
- Acronym
- DYSCOLIC
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2016
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35638103
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease - DYSCOLIC
- ClinicalTrials.gov ID
- NCT02726243
- Acronym / sponsor ID
- DYSCOLIC / NI13006
- Conditions
- Inflammatory Bowel Disease, Colorectal Cancer
- Keywords
- Inflammatory bowel disease, Crohn's Disease, Ulcerative Colitis, colorectal cancer, primary sclerosing cholangitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2014
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with or without an inflammatory bowel disease, for whom a colonoscopy is scheduled.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition of fecal microbiota by 16S sequencing
Time frame: Baseline
Microbiota composition will be assessed using MiSeq technology
1 secondary outcome
Profile of fecal bile acids
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 35638103Lavelle 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry SOKOL, MD PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Colorectal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of fecal microbiota by 16S sequencing (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.