Development of a Duodenal Organoid Model for Host-Intestinal Pathogen Interaction Studies (DuoDenOrg)

September 15, 2026 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

Development of an in Vitro Model Based on Human Duodenal Organoids for the Study of Host-Intestinal Pathogen Interactions

The goal of this clinical trial is to develop an in vitro model based on human duodenal organoids for the study of interactions between the human intestinal epithelium and enteric pathogens. Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue, will be asked to donate residual biological material for research purposes. The model generation procedure includes isolating intestinal stem cells from duodenal tissue, generating 3D intestinal organoids, expanding and differentiating the organoids, and inducing epithelial polarisation and maturation through air-liquid interface culture. Fully differentiated organoids will be used in in vitro co-culture experiments to assess pathogen viability, as well as the development of host epithelial responses to pathogens or their derivatives. Transcriptomic and proteomic data will also be obtained.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • 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 Contact

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • IRCCS Ospedale Sacro Cuore Don Calabria
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients subjected to surgical removal of a portion of the duodenum for clinical indications
Other: Donation of residual biological samples for the development of duodenal organoids.
Donation of residual biological samples for the development of duodenal organoids that will be tested for the study of host-intestinal pathogen interactions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of modifications in pathogen morphology, development, motility and viability induced by the maintenance in the model
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months
Determination of functional changes and gene expression modulation induced in human the human epithelial compartment following co-culture with the enteric pathogens
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months
Determination of functional changes and gene expression modulation induced in the human epithelial compartment following exposure to pathogen derivatives
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months

Collaborators and Investigators

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

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Collaborators

Universita di Verona

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)

June 9, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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