An interventional study of Donation of residual biological samples for the development of duodenal organoids. in Organoid and Model Disease, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Basic science
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.
IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Time frame: Through study completion, an average of 18 months
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
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IRCCS Sacro Cuore Don Calabria di Negrar