Inflammatory Bowel DiseasesCHIMICINCT03376230
Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Collect of blood, urines, and intestinal biopsies
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to 24 Jan 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600 divided into 3 groups: * 200 patients with ulcerative colitis * 200 patients with Crohn's disease * 200 control patients not suffering from inflammatory bowel disease and whose follow-up requires the realization of a coloscopy
Who may be able to join
- Patients who are at least 18 years old
- Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or "Control" patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)
- Patients requiring coloscopy as part of their medical follow-up
- Social insured.
Who cannot join
- Pregnant women
- Breastfeeding women
- People in emergency
- Persons unable to understand, read and / or sign informed consent
- Patients who recently had an intercurrent episode (eg recent diarrhea ...)
- Persons deprived of their liberty
- Persons protected by a legal protection status
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.
The aims of this clinical trial are:
- As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
- As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Collect of blood, urines, and intestinal biopsies
- Keywords
- Environmental risk factors, Xenobiotic detoxification
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect of blood, urines, and intestinal biopsiesOther
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Not described Receives: Other: Collect of blood, urines, and intestinal biopsies | |
| Crohn's disease patients | Not described Receives: Other: Collect of blood, urines, and intestinal biopsies | |
| Ulcerative colitis patients | Not described Receives: Other: Collect of blood, urines, and intestinal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
Measured: Baseline
Secondary outcomes (1)
Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study startFeb 2010
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: not enough recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Desreumeaux, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376230
- Sponsor's protocol ID
- 2009_13
- Other IDs
- 2010-A00056-33
- Acronym
- CHIMICI
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03376230
- Acronym / sponsor ID
- CHIMICI / 2009_13
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Environmental risk factors, Xenobiotic detoxification
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough recruitment
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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.
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.
The aims of this clinical trial are:
- As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
- As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control patients | – | Other: Collect of blood, urines, and intestinal biopsies |
| Crohn's disease patients | – | Other: Collect of blood, urines, and intestinal biopsies |
| Ulcerative colitis patients | – | Other: Collect of blood, urines, and intestinal biopsies |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600 divided into 3 groups: * 200 patients with ulcerative colitis * 200 patients with Crohn's disease * 200 control patients not suffering from inflammatory bowel disease and whose follow-up requires the realization of a coloscopy
Key inclusion criteria (4 listed)
- Patients who are at least 18 years old
- Has Crohn's disease or ulcerative colitis, diagnosed, confirmed by radiological and / or endoscopic examination within 4 years or "Control" patient not suffering from inflammatory bowel disease (patient with abdominal pain and / or persistent diarrhea, or patient requiring coloscopy for cancer of the digestive tract diagnosis)
- Patients requiring coloscopy as part of their medical follow-up
- Social insured.
Key exclusion criteria (7 listed)
- Pregnant women
- Breastfeeding women
- People in emergency
- Persons unable to understand, read and / or sign informed consent
- Patients who recently had an intercurrent episode (eg recent diarrhea ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect of blood, urines, and intestinal biopsies | Other | Control patients, Crohn's disease patients, Ulcerative colitis patients |
Primary outcome
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients.
Time frame: Baseline
1 secondary outcome
Comparison of expression pattern of genes involved in xenobiotics detoxification in intestinal mucosa in between the 3 groups of patients.
Time frame: Baseline
Results and safety
The study was stopped early (reason given: not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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.
Pierre Desreumeaux, MD, PhD principal investigator
University Hospital, Lille
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 Diseases, run by University Hospital, Lille 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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 was stopped early (reason given: not enough recruitment). Results are not available in the source record.
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?
Comparison of inflammatory response of biopsies to pollutants between the 3 groups of patients. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.