Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
Not applicable · Testing biological samples collection · 1 site · Artialis
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing biological samples collection (a procedure) to better understand how the disease works. Condition(s) listed: Inflammatory Bowel Disease (IBD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- General criteria:
- Male or female ≥ 18 years old
- Able to follow the instructions of the study
Plus 11 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2024-06-28.
- Main results expected around 2026-09-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Belgium.
Main thing being measured
- Number of patients recruited in each cohort (27 months)
In the researchers’ words
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Artialis |
| Enrollment | 120 (estimated) |
| Start date | 2024-06-28 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2024-07-16 |
| Last updated | 2026-01-28 |
| Official title | Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project) |
| ClinicalTrials.gov ID | NCT06502873 |
Interventions
- biological samples collection (Procedure)
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Full eligibility criteria (from the record)
Inclusion Criteria: General 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 IBD * Rectal or 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 * Patients with UC presenting inflammatory flare with: A clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg/g AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2 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: General 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,…)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Liège | Liège | Belgium | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.