An interventional study of Intestinal biopsies during colonoscopy and Biopsies taken on surgical specimen in Inflammatory Bowel Diseases, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-28.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Basic science
The exact origin of inflammatory bowel disease (IBD) is still unknown. The current hypothesis is that IBD is secondary to an abnormal intestinal immun response directed to all or part of the intestinal flora in genetically predisposed individuals. Several experimental studies have demonstrated the ability of mesenchymal stem cells (MSCs) from bone marrow or adipose tissue origin to control intestinal inflammation in animal models. However, to date, there are no data regarding the functions of resident MSCs in the colon and small intestine of IBD patients. We hypothesize that dysfunction of resident intestinal MSCs contributes to the disruption of intestinal homeostasis in patients with IBD causing the development of intestinal inflammation. The aim of this research project is to identify, describe and characterize at the molecular and functional level MSCs of the colon and small intestine of patients with Crohn's disease and ulcerative colitis and to compare them with a control population.
Primary and secondary objectives:
Main Objective: Characterize morphologically, molecularly and functionally the MSCs of colon and small intestine of patients with IBD and compared to MSCs of colon and small intestine of control patients.
Secondary objectives: To study the reaction of colon and small intestine MHC in patients with IBD following stimulation with bacterial compounds.
Methodology:
Clinical study exploratory translational physiopathological. Two groups of patients with Crohn's disease and ulcerative colitis who require colonoscopy or surgery for intestinal resection will be included. These two groups will be compared to a control group consisting of patients requiring colonoscopy for screening or intestinal resection for colorectal cancer or diverticulum.
Intestinal sampling by biopsy during the colonoscopy or with surgical specimen during the surgery will be performed to isolate the MSCs.
The outcome measures will be a qualitative and quantitative analysis of MSCs by immunohistochemistry, immunofluorescence, cell proliferation and differentiation, production of pro- and anti-inflammatory cytokines in the basal state and after bacterial stimulation.
Total of 60 patients (20 in groups, 15 with colonoscopy and 5 with surgical specimens).
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 2 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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For IBD patients :
For control patients :
Exclusion criteria:
For IBD patients :
For control patients :
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Other: Intestinal biopsies during colonoscopy · Other: Biopsies taken on surgical specimen
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Other: Intestinal biopsies during colonoscopy · Other: Biopsies taken on surgical specimen
Intestinal biopsies during colonoscopy or biopsies taken on surgical specimen after intestinal resection
Other: Intestinal biopsies during colonoscopy · Other: Biopsies taken on surgical specimen
Intestinal biopsies during colonoscopy
biopsies taken on surgical specimen after intestinal resection
Proliferation and differentiation of intestinal MSCs in IBD patients.
Proliferation and differentiation of intestinal MSCs in IBD patients.
Time frame: 1 month
Comparison of MSCs between IBD patients and control patients
Comparison of MSCs between IBD patients and control patients using mmunohistochemistry, immunofluorescence, quantification of pro- and anti-inflammatory cytokines production.
Time frame: 1 month
Plan to share: No
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier