Viral Gastroenteritis Clinical Trials

Find Viral Gastroenteritis Clinical Trials Near You

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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Belgium
CHU de Liège
RECRUITING
Liège
Contact Information
Primary
Bérénice Costes
berenice.costes@artialis.com
042670888
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Other: Inflammatory bowel disease cohort
60 patients diagnosed with colonic inflammatory bowel disease
Other: Control cohort
60 control patients without inflammatory bowel diseases
Related Therapeutic Areas
Sponsors
Leads: Artialis

This content was sourced from clinicaltrials.gov