Intestinal Organoids (BIOÏDES)
Primary Purpose
Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional biopsies
Sponsored by
About this trial
This is an interventional other trial for Digestive System Diseases focused on measuring biobank, organoids, digestive disease, inflammatory bowel disease
Eligibility Criteria
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)
Sites / Locations
- CHU de RENNES-Service des Maladies de l'Appareil DigestifRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group Crohn's disease
Group ulcerative colitis
Group No MICI
Arm Description
4 additional biopsies for 30 patients with Crohn's disease
4 additional biopsies for 30 patients with ulcerative colitis
4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of differentiated organoids
Fold change of MUC2 expression
Fold change of LGR5 expression
KI67 expression
Full Information
NCT ID
NCT05294107
First Posted
February 28, 2022
Last Updated
September 12, 2022
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05294107
Brief Title
Intestinal Organoids
Acronym
BIOÏDES
Official Title
Intestinal Organoids
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease
Keywords
biobank, organoids, digestive disease, inflammatory bowel disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, monocentric cohort aiming at generating 3D organoids from human digestive samples
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Crohn's disease
Arm Type
Experimental
Arm Description
4 additional biopsies for 30 patients with Crohn's disease
Arm Title
Group ulcerative colitis
Arm Type
Experimental
Arm Description
4 additional biopsies for 30 patients with ulcerative colitis
Arm Title
Group No MICI
Arm Type
Active Comparator
Arm Description
4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease
Intervention Type
Procedure
Intervention Name(s)
additional biopsies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of isolated intestinal crypts per biopsies
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Number of differentiated organoids
Time Frame
Day 0
Title
Fold change of MUC2 expression
Time Frame
Day 0
Title
Fold change of LGR5 expression
Time Frame
Day 0
Title
KI67 expression
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume BOUGUEN, Professor
Phone
2 99 28 99 72
Ext
+33
Email
guillaume.bouguen@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume BOUGUEN, Professor
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de RENNES-Service des Maladies de l'Appareil Digestif
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BOUGUEN, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
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Intestinal Organoids
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