Development of a Duodenal Organoid Model for Host-Intestinal Pathogen Interaction Studies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Absence of informed written consent
Inadequate amount of histologically normal duodenal tissue
Trial design
Design model
Single group
Treatments tested in this trial
Donation of residual biological samples for the development of duodenal organoids.
Other interventionDonation of residual biological samples for the development of duodenal organoids that will be tested for the study of host-intestinal pathogen interactions
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Patients subjected to surgical removal of a portion of the duodenum for clinical indicationsOther 1 intervention
Trial outcomes
Primary outcomes
1
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Time frame
Through study completion, an average of 18 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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IRCCS Sacro Cuore Don Calabria di Negrar
Lead sponsor
Universita di Verona
Collaborator
Source ClinicalTrials.gov