Radiation EnteritisINTRUSTNCT05425901
Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
A study testing biopsy in people with Radiation Enteritis and Inflammatory Bowel Diseases, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Enteritis, Inflammatory Bowel Diseases
- What is being tested?
- biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2022to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1: active IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
- Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
Show all 19Show fewer
- Or
- Group 2: inactive IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to ECCO 2019 consensus criteria
- Inactive IBD (Harvey-Bradshaw score below 4 for Crohn's disease or partial Mayo score below 3 for ulcerative colitis)
- Indication to perform a coloscopy
- Written consent for study participation obtained
- Or
- Group 3: Control
- 18 years old or older
- Indication to perform a coloscopy to detect polyp
- No known bowel disease
- Written consent for study participation obtained
Who cannot join
- Inability to understand, read, sign informed consent and/or express consent
- Person subject to legal protection (curator, guardianship or safeguard of justice),
- Deprivation of liberty by judicial or administrative decision,
- Non-affiliation to a social security scheme or non-beneficiary of such a scheme
- Pregnant, parturient, breastfeeding women
- Contraindication to performing biopsies
Show all 10Show fewer
- Participation in other therapeutic research that may modify the behavior of intestinal cells (for example, drug research for the treatment of IBD)
- Anticoagulant treatment or bleeding disorder
- Person subject to a judicial safeguard measure
- People hospitalized without consent
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Ambroise Paré Hartmann
Neuilly-sur-Seine, Hauts-de-Seine, 92200
About this study
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
- Conditions
- Radiation Enteritis, Inflammatory Bowel Diseases
- Being tested
- biopsy
- Keywords
- colonoscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
endoscopy biopsies (6)
| Study group | Role | What they receive |
|---|---|---|
| IBD | Experimental | active or quiescent Receives: Other: biopsy |
| control | Active comparator | polyp screening Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of organoid-production method - quantity
Quantity of organoids created
Measured: Day 1
Validation of organoid-production method - size
Size of organoids created
Measured: Day 1
Validation of organoid-production method - cell growth
Cell-growth kinetics
Measured: Day 1
Validation of organoid-production method - cell composition
Cell composition assessed by immunofluorescence
Measured: Day 1
Validation of organoid-production method - cell composition
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Measured: Day 1
Validation of organoid-production method - cell apoptosis
Cell-apoptosis level assessed by immunofluorescence
Measured: Day 1
Validation of organoid-production method - tight junctions
Number of tight junctions between cells assessed by immunofluorescence
Measured: Day 1
Secondary outcomes (15)
Screening-tool setup - quantity
Quantity of organoids after irradiation
Measured: Day 1
Screening-tool setup - size
Size of organoids after irradiation
Measured: Day 1
Screening-tool setup - cell growth
Cell-growth kinetics after irradiation
Measured: Day 1
Screening-tool setup - cell composition
Cell composition after irradiation assessed by immunofluorescence
Measured: Day 1
Screening-tool setup - cell apoptosis
Cell-apoptosis level after irradiation assessed by immunofluorescence
Measured: Day 1
Screening-tool setup - tight junctions
Number of tight junctions between cells after irradiation assessed by immunofluorescence
Measured: Day 1
Screening-tool setup - inflammatory cytokines
Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing
Measured: Day 1
In-vitro treatment evaluation - quantity
Quantity of organoids after irradiation and in presence of treatment
Measured: Day 1
In-vitro treatment evaluation - size
Size of organoids after irradiation and in presence of treatment
Measured: Day 1
In-vitro treatment evaluation - cell growth
Cell-growth kinetics after irradiation and in presence of treatment
Measured: Day 1
In-vitro treatment evaluation - cell composition
Cell composition after irradiation and in presence of treatment assessed by immunofluorescence
Measured: Day 1
In-vitro treatment evaluation - cell composition
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Measured: Day 1
In-vitro treatment evaluation - cell apoptosis
Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence
Measured: Day 1
In-vitro treatment evaluation - tight junction
Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence
Measured: Day 1
In-vitro treatment evaluation - inflammatory cytokines
Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start19 Sep 2022
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EnteritisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425901
- Sponsor's protocol ID
- C20-53
- Other IDs
- 2021-A02973-38
- Acronym
- INTRUST
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids
- ClinicalTrials.gov ID
- NCT05425901
- Acronym / sponsor ID
- INTRUST / C20-53
- Conditions
- Radiation Enteritis, Inflammatory Bowel Diseases
- Keywords
- colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- National Research Agency, France
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 21 Jun 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.
This study is carried out in patients with IBD and healthy subjects requiring ileocolonoscopy as part of routine care (disease monitoring or polyp/colon cancer screening). It aims the generation and culturing of organoids from digestive biopsies recovered from healthy and/or pathological (inflammatory) ileal and/or colonic mucosa during an ileo-colonoscopy. These cultures will make it possible to validate the organoid production method used in the context of the research (primary objective). In a second phase (secondary objectives), the study will aim to setup a screening tool by irradiating the organoids (step one) and then evaluate in vitro the regenerative activity of treatments dedicated to improve inflammatory bowel diseases and acute radiation enteritis (step two).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD | Experimental | Other: biopsyactive or quiescent |
| control | Active comparator | Other: biopsypolyp screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Group 1: active IBD
- 18 years old or older
- Assured IBD diagnosis (Crohn's disease/ulcerative colitis) according to European Crohn's and Colitis Organisation (ECCO) 2019 consensus criteria
- Active IBD (Harvey-Bradshaw score of 4 or above for Crohn's disease or partial Mayo score of 3 or above for ulcerative colitis)
- Indication to perform a coloscopy
Key exclusion criteria (10 listed)
- Inability to understand, read, sign informed consent and/or express consent
- Person subject to legal protection (curator, guardianship or safeguard of justice),
- Deprivation of liberty by judicial or administrative decision,
- Non-affiliation to a social security scheme or non-beneficiary of such a scheme
- Pregnant, parturient, breastfeeding women
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 |
|---|---|---|
| biopsyendoscopy biopsies (6) | Other | IBD, control |
Primary outcome
Validation of organoid-production method - quantity
Time frame: Day 1
Quantity of organoids created
Validation of organoid-production method - size
Time frame: Day 1
Size of organoids created
Validation of organoid-production method - cell growth
Time frame: Day 1
Cell-growth kinetics
Validation of organoid-production method - cell composition
Time frame: Day 1
Cell composition assessed by immunofluorescence
Validation of organoid-production method - cell composition
Time frame: Day 1
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Validation of organoid-production method - cell apoptosis
Time frame: Day 1
Cell-apoptosis level assessed by immunofluorescence
Validation of organoid-production method - tight junctions
Time frame: Day 1
Number of tight junctions between cells assessed by immunofluorescence
15 secondary outcomes
Screening-tool setup - quantity
Time frame: Day 1
Screening-tool setup - size
Time frame: Day 1
Screening-tool setup - cell growth
Time frame: Day 1
Screening-tool setup - cell composition
Time frame: Day 1
Screening-tool setup - cell apoptosis
Time frame: Day 1
Screening-tool setup - tight junctions
Time frame: Day 1
Screening-tool setup - inflammatory cytokines
Time frame: Day 1
In-vitro treatment evaluation - quantity
Time frame: Day 1
In-vitro treatment evaluation - size
Time frame: Day 1
In-vitro treatment evaluation - cell growth
Time frame: Day 1
In-vitro treatment evaluation - cell composition
Time frame: Day 1
In-vitro treatment evaluation - cell composition
Time frame: Day 1
In-vitro treatment evaluation - cell apoptosis
Time frame: Day 1
In-vitro treatment evaluation - tight junction
Time frame: Day 1
In-vitro treatment evaluation - inflammatory cytokines
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
Related trials for Radiation Enteritis
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
Not yet recruitingObservational study
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
Radiation Enteritis
Not yet recruitingPhase 2
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Acute Radiation Enteritis
RecruitingPhase 2
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.
Radiation Enteritis
Active, not recruitingPhase 1/2
CMTS0515-auWMT for Radiation Enteritis
Radiation Enteritis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Radiation Enteritis and Inflammatory Bowel Diseases, run by Institut National de la Santé Et de la Recherche Médicale, France 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 19 inclusion and 10 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: finished, as of the sponsor's last update on 18 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of organoid-production method - quantity (time frame: Day 1). The study lists 7 primary outcomes in all. 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 18 Sep 2025.