Intestinal Organoids

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Disease, Ulcerative Colitis Type; Crohn Disease; Digestive System Diseases
• Interventions: Procedure: additional biopsies

• Registration Number: NCT05294107
• Lead Sponsor: Rennes University Hospital

Brief Summary

Over the last decade, the use of mini-organ or organoids has been increasingly developed in fundamental research. Indeed, digestive organoids represent an essential advance compared to classical culture systems (epithelial cell lines, immortalized cells) since they preserve in culture the functional complexity present in vivo (architecture, different cell types). They also have the advantage of being able to be propagated indefinitely (unlike explants), minimizing the use of animal models and reducing the amount of tissue required. Finally, their growth and development depends on the origin of the sample (the organoid will develop differently if the cell source comes from a patient suffering from an inflammatory bowel disease, for example), thus generating models of human pathologies to better determine their physiopathology. The use of organoids in biomedical research has proven to be an indispensable tool for the understanding of cellular and molecular mechanisms involved in epithelial renewal and the screening of molecules and ingredients for applications in the health and agri-food sectors.

Detailed Description

The project aims to generate a biocollection of 3D intestinal models from digestive biopsies with associated health data and to characterize them before using them for the screening of potential therapeutic molecules.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-09-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjects aged 18 to 75 years
• Subject undergoing endoscopy as part of the standard of care with the need to take digestive biopsy samples
• Subject having signed a free and informed consent in writing

Exclusion Criteria

• Subjects under legal protection (safeguard of justice, curatorship or guardianship) or deprived of liberty.
• Anticoagulant treatment and anti-platelet treatment (except for aspirin 75 mg)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group ulcerative colitis	additional biopsies	4 additional biopsies for 30 patients with ulcerative colitis
Group No MICI	additional biopsies	4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease
Group Crohn's disease	additional biopsies	4 additional biopsies for 30 patients with Crohn's disease

Primary Outcome Measures

Name	Time	Method
Number of isolated intestinal crypts per biopsies	Day 0	Biopsies will be then prepared by isolating intestinal crypts and cultured on a 3D matrix gel (matrigel) with added growth factors reproducing the niche environment of intestinal stem cells, which favors the development of an intestinal epithelium. After intestinal differentiation, organoids will be used for research such as molecular screening, assessment of the effects of intestinal stress and healing.

Secondary Outcome Measures

Name	Time	Method
Number of differentiated organoids	Day 0
Fold change of MUC2 expression	Day 0
Fold change of LGR5 expression	Day 0
KI67 expression	Day 0

Trial Locations

Locations (1)

CHU de RENNES-Service des Maladies de l'Appareil Digestif; 🇫🇷 Rennes, France