Intestinal Organoids

NCT05294107 | Active Not Recruiting

• 1 other identifier: 35RC21_8862_BIOÏDES
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System Diseases; Inflammatory Bowel Disease, Ulcerative Colitis Type; Crohn Disease

Keywords

biobank; organoids; digestive disease; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of differentiated organoids

  Day 0

• Fold change of MUC2 expression

  Day 0

• Fold change of LGR5 expression

  Day 0

• KI67 expression

  Day 0

Study Arms (3)

Group Crohn's disease

EXPERIMENTAL

4 additional biopsies for 30 patients with Crohn's disease

Procedure: additional biopsies

Group ulcerative colitis

EXPERIMENTAL

4 additional biopsies for 30 patients with ulcerative colitis

Procedure: additional biopsies

Group No MICI

ACTIVE COMPARATOR

4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease

Procedure: additional biopsies

Interventions

additional biopsies PROCEDURE

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.

Group Crohn's disease; Group No MICI; Group ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de RENNES-Service des Maladies de l'Appareil Digestif

Rennes, France

Location

MeSH Terms

Conditions

Digestive System Diseases; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Guillaume BOUGUEN, Professor

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric cohort aiming at generating 3D organoids from human digestive samples

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 24, 2022
• Study Start: September 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)