Digestive System DiseasesBIOÏDESNCT05294107
Intestinal Organoids
A study testing additional biopsies in people with Digestive System Diseases and Inflammatory Bowel Disease, Ulcerative Colitis Type, run by Rennes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease
- What is being tested?
- additional biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 7 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de RENNES-Service des Maladies de l'Appareil Digestif
Rennes
Guillaume BOUGUEN, Professor
About this study
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.
Read the 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.
- Conditions
- Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease
- Being tested
- additional biopsies
- Keywords
- biobank, organoids, digestive disease, inflammatory bowel disease
- Medical subject headings
- Digestive System Diseases, Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional biopsiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Crohn's disease | Experimental | 4 additional biopsies for 30 patients with Crohn's disease Receives: Procedure: additional biopsies |
| Group ulcerative colitis | Experimental | 4 additional biopsies for 30 patients with ulcerative colitis Receives: Procedure: additional biopsies |
| Group No MICI | Active comparator | 4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease Receives: Procedure: additional biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
Number of differentiated organoids
Measured: Day 0
Fold change of MUC2 expression
Measured: Day 0
Fold change of LGR5 expression
Measured: Day 0
KI67 expression
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start6 Sep 2022
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric cohort aiming at generating 3D organoids from human digestive samples
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BOUGUEN, Professor, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294107
- Sponsor's protocol ID
- 35RC21_8862_BIOÏDES
- Acronym
- BIOÏDES
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Organoids
- ClinicalTrials.gov ID
- NCT05294107
- Acronym / sponsor ID
- BIOÏDES / 35RC21_8862_BIOÏDES
- Conditions
- Digestive System Diseases, Inflammatory Bowel Disease, Ulcerative Colitis Type, Crohn Disease
- Keywords
- biobank, organoids, digestive disease, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, monocentric cohort aiming at generating 3D organoids from human digestive samples
| Arm | Type | Receives |
|---|---|---|
| Group Crohn's disease | Experimental | Procedure: additional biopsies4 additional biopsies for 30 patients with Crohn's disease |
| Group ulcerative colitis | Experimental | Procedure: additional biopsies4 additional biopsies for 30 patients with ulcerative colitis |
| Group No MICI | Active comparator | Procedure: additional biopsies4 additional biopsies for 30 patients out of Inflammatory Disease Chronic Bowel Disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional biopsiesAfter 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. | Procedure or surgery | Group Crohn's disease, Group No MICI, Group ulcerative colitis |
Primary outcome
Number of isolated intestinal crypts per biopsies
Time frame: 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.
4 secondary outcomes
Number of differentiated organoids
Time frame: Day 0
Fold change of MUC2 expression
Time frame: Day 0
Fold change of LGR5 expression
Time frame: Day 0
KI67 expression
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume BOUGUEN, Professor principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional biopsies in people with Digestive System Diseases and Inflammatory Bowel Disease, Ulcerative Colitis Type, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume BOUGUEN, Professor (2 99 28 99 72 ext. +33, guillaume.bouguen@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of isolated intestinal crypts per biopsies (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.