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Miniature gut models could reveal how pathogens attack the intestine

NCT ID NCT07828665

Knowledge-focused Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers aim to build a laboratory model of the human duodenum using organoids, tiny three-dimensional clusters of gut cells grown from donated tissue. People having part of their duodenum removed for medical reasons can donate leftover, healthy-looking tissue. The team isolates stem cells, grows them into organoids, matures them, and then exposes them to intestinal pathogens to observe how the germs behave and how the gut cells respond.

What this could mean

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

Active substance
Donation of residual duodenal tissue for growing intestinal organoids
What this could lead to
If it works, this could give researchers a lab model of the human gut lining to study how infections start and how the body responds.
What could go wrong
This is a small laboratory study with six tissue donors, so the model may not fully mimic a living human gut. Organoids can fail to grow or behave differently from real tissue.

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

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue; * Availability of written informed consent for the use of biological samples for research purposes. Exclusion Criteria: * Absence of informed written consent * Inadequate amount of histologically normal duodenal tissue

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As listed by the trial registrant

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

Model disease Organoid

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • IRCCS Ospedale Sacro Cuore Don Calabria

    RECRUITING

    Negrar, Verona, 37024, Italy

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