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Mini organs from biopsies could revolutionize gut disease research

NCT ID NCT05425901

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study takes small tissue samples from people with inflammatory bowel disease (IBD) and healthy volunteers to grow 'mini guts' (organoids) in the lab. Researchers will then expose these organoids to radiation to mimic radiation enteritis and test potential treatments. The goal is to create a reliable screening tool for new therapies, not to treat participants directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could create a lab-grown model to screen drugs for IBD and radiation gut damage, speeding up discovery of new treatments.
What could go wrong
This is a very early, small study (16 people) focused on building a tool, not testing a treatment. The organoid model may not fully mimic human disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease enteritis inflammatory bowel disease radiation proctitis ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel diseases Radiation enteritis

Contacts and locations

Locations

  • Groupe Hospitalier Ambroise Paré Hartmann

    Neuilly-sur-Seine, Hauts-de-Seine, 92200, France

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