Crohn's DiseaseMOBIDICNCT02882841
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
A study testing Biopsies, stool and blood collection in people with Crohn's Disease, run by Enterome at 3 sites in 3 countries.
Trial summary
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Biopsies, stool and blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2016to Dec 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 75 years of age, inclusive;
- With a diagnosis of ileal or ileo-colonic Crohn's disease for a minimum of 3 months prior to inclusion;
- An ileocolonoscopy scheduled prior to study inclusion;
- Agreeing to participate and to sign an informed consent form;
- Able to perform stool collection, at home, according to protocol;
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- Colonic Crohn's disease of L2 phenotype based on Montreal classification;
- Extensive small bowel resection (> 100 cm) or short bowel syndrome
- Bowel strictures/stenosis contraindicating ilecolonoscopy;
- Currently with an ostomy or an ileoanal pouch;
- Currently receiving total parenteral nutrition;
- Bowel preparation received in the previous 3 months;
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- An increased risk of hemorrhage (patients with anticoagulant/antiplatelet therapy)
- History of intestinal carcinoma and colorectal cancer;
- History or presence of alcohol or substance abuse;
- History of chronic uncontrolled disorders;
- Current participation in an investigational product trial;
- Less than 4 weeks since last participation in a clinical trial;
- Subject inapt or unwilling to participate to the study;
- Pregnant or breastfeeding mother;
- Patient under guardianship.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.
At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.
Read the detailed description
350 Crohn's disease patients will be included in the study, targeting 300 evaluable patients. An interim analysis will be performed after 50% of the evaluable patients are recruited.
The primary objective is to evaluate the relation between non-invasive biomarkers (host immunological variables and metagenomic analysis in stools) and AIEC detection in biopsies taken during an endoscopy, in order to develop a predictive algorithm of AIEC carriage.
The secondary objectives are:
- Validation of the AIEC detection algorithm using qPCR technology.
- Assessment of the correlation between the presence of AIEC and the endoscopic and clinical evaluations of the disease (CDEIS, SES-CD, Harvey-Bradshaw Index and Crohn's Disease Activity Index).
- Development and validation of a non-invasive qPCR based diagnostic of Mucosal Healing in CD patients.
- Collection of biological samples associated with all clinical and biological data from CD patients.
- Conditions
- Crohn's Disease
- Being tested
- Biopsies, stool and blood collection
- Keywords
- AIEC (Adherent and Invasive Escherichia Coli), Mucosal Healing, Non-invasive biomarkers
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies, stool and blood collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Other | Not described Receives: Other: Biopsies, stool and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary evaluation criterion is the correlation between the detection of AIEC using a non-invasive stool based algorithm and the detection of AIEC using an ileal biopsy taken during an endoscopy.
Measured: 6-12 months between inclusion and analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882841
- Sponsor's protocol ID
- IBD210
- Acronym
- MOBIDIC
- Status last verified
- Apr 2018
- First submitted
- 25 Aug 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients (MOBIDIC)
- ClinicalTrials.gov ID
- NCT02882841
- Acronym / sponsor ID
- MOBIDIC / IBD210
- Conditions
- Crohn's Disease
- Keywords
- AIEC (Adherent and Invasive Escherichia Coli), Mucosal Healing, Non-invasive biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 143 participants (actual)
- Lead sponsor
- EnteromeIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Aug 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.
The study is a multicenter, international descriptive study with a bio-collection in 300 evaluable Crohn's disease patients to be processed after usual biological tests via bioinformatics tools.
At this time, this study has no impact neither on treatment nor on disease diagnostic, these will be based on usual medical practices and is no investigational product associated with the conduct of this study.
Detailed description
350 Crohn's disease patients will be included in the study, targeting 300 evaluable patients. An interim analysis will be performed after 50% of the evaluable patients are recruited.
The primary objective is to evaluate the relation between non-invasive biomarkers (host immunological variables and metagenomic analysis in stools) and AIEC detection in biopsies taken during an endoscopy, in order to develop a predictive algorithm of AIEC carriage.
The secondary objectives are:
- Validation of the AIEC detection algorithm using qPCR technology.
- Assessment of the correlation between the presence of AIEC and the endoscopic and clinical evaluations of the disease (CDEIS, SES-CD, Harvey-Bradshaw Index and Crohn's Disease Activity Index).
- Development and validation of a non-invasive qPCR based diagnostic of Mucosal Healing in CD patients.
- Collection of biological samples associated with all clinical and biological data from CD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Other | Other: Biopsies, stool and blood collection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female between 18 and 75 years of age, inclusive;
- With a diagnosis of ileal or ileo-colonic Crohn's disease for a minimum of 3 months prior to inclusion;
- An ileocolonoscopy scheduled prior to study inclusion;
- Agreeing to participate and to sign an informed consent form;
- Able to perform stool collection, at home, according to protocol;
Key exclusion criteria (15 listed)
- Colonic Crohn's disease of L2 phenotype based on Montreal classification;
- Extensive small bowel resection (> 100 cm) or short bowel syndrome
- Bowel strictures/stenosis contraindicating ilecolonoscopy;
- Currently with an ostomy or an ileoanal pouch;
- Currently receiving total parenteral nutrition;
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 |
|---|---|---|
| Biopsies, stool and blood collection | Other | Single-arm study |
Primary outcome
The primary evaluation criterion is the correlation between the detection of AIEC using a non-invasive stool based algorithm and the detection of AIEC using an ileal biopsy taken during an endoscopy.
Time frame: 6-12 months between inclusion and analysis
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies, stool and blood collection in people with Crohn's Disease, run by Enterome at 3 sites in 3 countries.
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 6 inclusion and 15 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France, United Kingdom. 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: Poor accrual). 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?
The primary evaluation criterion is the correlation between the detection of AIEC using a non-invasive stool based algorithm and the detection of AIEC using an ileal biopsy taken during an endoscopy. (time frame: 6-12 months between inclusion and analysis). 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 12 Jun 2018.