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New treatment option for Inflammatory Bowel Disease (IBD)
Official title Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT06502873
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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,…)
The study team makes the final eligibility decision.
Where it's taking place
- Liège, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liège, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.