Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
NCT ID: NCT06502873
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2024-06-28
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease
NCT06720961
Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
NCT06770140
Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
NCT03566407
Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
NCT01349920
Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
NCT03712826
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Crohn disease cohort
60 patients diagnosed with colonic or ileocolic Crohn disease
biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Control cohort
60 control patients without inflammatory bowel diseases
biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female ≥ 18 years old
* Able to follow the instructions of the study
* Having signed an informed consent
Specific for Crohn cohort:
* A confirmed diagnosis of CD
* Colonic or ileocolic involvement
* Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:
* A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index \> 8 OR a faecal calprotectin ≥ 250 µg/g And
* A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7
Specific for Control cohort:
Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)
Exclusion Criteria
* Commercial Pharmaceutical probiotic administration within the previous month
* Treatment with antibiotics (whatever the route of administration) within last 3 months
* Non-remission Cancer or in remission for less than 6 months
* Any contraindication to colonoscopy and/or biopsy, left to PI discretion
* Under guardianship or judiciable protection
* Pregnant or breastfeeding women
* Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement
Specific for Crohn cohort:
* Crohn disease localized only in Ileum
* Inflammatory colon pathology other than Crohn's (infectious, drug-induced,…)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Artialis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sophie Vieujean, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Liege
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Liège
Liège, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ELITE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.