Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids (INTRUST)

September 17, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-Seine
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • Groupe Hospitalier Ambroise Paré Hartmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

- 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

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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IBD
active or quiescent
Other: biopsy
endoscopy biopsies (6)
Active Comparator: control
polyp screening
Other: biopsy
endoscopy biopsies (6)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validation of organoid-production method - quantity
Time Frame: Day 1
Quantity of organoids created
Day 1
Validation of organoid-production method - size
Time Frame: Day 1
Size of organoids created
Day 1
Validation of organoid-production method - cell growth
Time Frame: Day 1
Cell-growth kinetics
Day 1
Validation of organoid-production method - cell composition
Time Frame: Day 1
Cell composition assessed by immunofluorescence
Day 1
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
Day 1
Validation of organoid-production method - cell apoptosis
Time Frame: Day 1
Cell-apoptosis level assessed by immunofluorescence
Day 1
Validation of organoid-production method - tight junctions
Time Frame: Day 1
Number of tight junctions between cells assessed by immunofluorescence
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Screening-tool setup - quantity
Time Frame: Day 1
Quantity of organoids after irradiation
Day 1
Screening-tool setup - size
Time Frame: Day 1
Size of organoids after irradiation
Day 1
Screening-tool setup - cell growth
Time Frame: Day 1
Cell-growth kinetics after irradiation
Day 1
Screening-tool setup - cell composition
Time Frame: Day 1
Cell composition after irradiation assessed by immunofluorescence
Day 1
Screening-tool setup - cell apoptosis
Time Frame: Day 1
Cell-apoptosis level after irradiation assessed by immunofluorescence
Day 1
Screening-tool setup - tight junctions
Time Frame: Day 1
Number of tight junctions between cells after irradiation assessed by immunofluorescence
Day 1
Screening-tool setup - inflammatory cytokines
Time Frame: Day 1
Level of inflammatory-cytokines produced after irradiation assessed by single-cell RNA sequencing
Day 1
In-vitro treatment evaluation - quantity
Time Frame: Day 1
Quantity of organoids after irradiation and in presence of treatment
Day 1
In-vitro treatment evaluation - size
Time Frame: Day 1
Size of organoids after irradiation and in presence of treatment
Day 1
In-vitro treatment evaluation - cell growth
Time Frame: Day 1
Cell-growth kinetics after irradiation and in presence of treatment
Day 1
In-vitro treatment evaluation - cell composition
Time Frame: Day 1
Cell composition after irradiation and in presence of treatment assessed by immunofluorescence
Day 1
In-vitro treatment evaluation - cell composition
Time Frame: Day 1
Cell composition compared to native-biopsy cell composition assessed by single-cell RNA sequencing
Day 1
In-vitro treatment evaluation - cell apoptosis
Time Frame: Day 1
Cell-apoptosis level after irradiation and in presence of treatment assessed by immunofluorescence
Day 1
In-vitro treatment evaluation - tight junction
Time Frame: Day 1
Number of tight junctions between cells after irradiation and in presence of treatment assessed by immunofluorescence
Day 1
In-vitro treatment evaluation - inflammatory cytokines
Time Frame: Day 1
Level of inflammatory-cytokines produced after irradiation and in presence of treatment assessed by single-cell RNA sequencing
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Agency, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C20-53
  • 2021-A02973-38 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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