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

NCT07828665 | Recruiting

• 1 other identifier: 2026-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Organoid; Model Disease

Keywords

Organoid; In vitro model; pathogen interactions

Outcome Measures

Primary Outcomes (1)

• Successful generation of stable and expandable human duodenal organoids from duodenal tissue

  Through study completion, an average of 18 months

Secondary Outcomes (3)

• Determination of modifications in pathogen morphology, development, motility and viability induced by the maintenance in the model

  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

  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

  Through study completion, an average of 18 months

Study Arms (1)

Patients subjected to surgical removal of a portion of the duodenum for clinical indications

OTHER

Other: Donation of residual biological samples for the development of duodenal organoids.

Interventions

Donation of residual biological samples for the development of duodenal organoids. OTHER

Donation of residual biological samples for the development of duodenal organoids that will be tested for the study of host-intestinal pathogen interactions

Patients subjected to surgical removal of a portion of the duodenum for clinical indications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Absence of informed written consent
• Inadequate amount of histologically normal duodenal tissue

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead
• Universita di Verona: collaborator

Study Sites (1)

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

RECRUITING

Central Study Contacts

Elvia Malo, Dr.

CONTACT

+39 0456014854; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients subjected to surgical removal of a portion of the duodenum for clinical indications will donate residual biological samples for the development of duodenal organoids.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 18, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)