Intestinal Organoids (BIOÏDES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Digestive System Diseases; Crohn Disease; Inflammatory Bowel Disease, Ulcerative Colitis Type
• Intervention / Treatment: Procedure: additional biopsies

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • CHU de RENNES-Service des Maladies de l'Appareil Digestif

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Crohn's disease; 4 additional biopsies for 30 patients with Crohn's disease	Procedure: additional biopsies; After Verification of eligibility criteria, patient information and consent, digestive biopsies performed for the study are in addition to those performed for the patient's follow-up: 6 biopsies are taken on average in clinical routine; 4 additional biopsies are necessary to obtain a sufficient number of amplifiable stem cells The samples will be sent within one hour to the Biological Resource Center of the University Hospital of Rennes at room temperature in a tube containing isotonic saline. (CRB). 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.
Experimental: Group ulcerative colitis; 4 additional biopsies for 30 patients with ulcerative colitis	Procedure: additional biopsies; After Verification of eligibility criteria, patient information and consent, digestive biopsies performed for the study are in addition to those performed for the patient's follow-up: 6 biopsies are taken on average in clinical routine; 4 additional biopsies are necessary to obtain a sufficient number of amplifiable stem cells The samples will be sent within one hour to the Biological Resource Center of the University Hospital of Rennes at room temperature in a tube containing isotonic saline. (CRB). 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.
Active Comparator: Group No MICI; 4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease	Procedure: additional biopsies; After Verification of eligibility criteria, patient information and consent, digestive biopsies performed for the study are in addition to those performed for the patient's follow-up: 6 biopsies are taken on average in clinical routine; 4 additional biopsies are necessary to obtain a sufficient number of amplifiable stem cells The samples will be sent within one hour to the Biological Resource Center of the University Hospital of Rennes at room temperature in a tube containing isotonic saline. (CRB). 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of isolated intestinal crypts per biopsies	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.	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of differentiated organoids	Day 0
Fold change of MUC2 expression	Day 0
Fold change of LGR5 expression	Day 0
KI67 expression	Day 0

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Guillaume BOUGUEN, Professor, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: biobank; inflammatory bowel disease; organoids; digestive disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Digestive System Diseases; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 35RC21_8862_BIOÏDES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No