Development of a Duodenal Organoid Model for Host-Intestinal Pathogen Interaction Studies (DuoDenOrg)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Elvia Malo, Dr.
- Telefonnummer: +39 0456014854
- E-mail: ricerca.clinica@sacrocuore.it
Studiesteder
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Verona
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Negrar, Verona, Italien, 37024
- Rekruttering
- IRCCS Ospedale Sacro Cuore Don Calabria
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Kontakt:
- Michela Deiana, Dr.
- Telefonnummer: +39 0456013311
- E-mail: michela.deiana@sacrocuore.it
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Patients subjected to surgical removal of a portion of the duodenum for clinical indications
|
Donation of residual biological samples for the development of duodenal organoids that will be tested for the study of host-intestinal pathogen interactions |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Tidsramme: Through study completion, an average of 18 months
|
Through study completion, an average of 18 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Determination of modifications in pathogen morphology, development, motility and viability induced by the maintenance in the model
Tidsramme: 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
Tidsramme: Through study completion, an average of 18 months
|
Through study completion, an average of 18 months
|
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Determination of functional changes and gene expression modulation induced in the human epithelial compartment following exposure to pathogen derivatives
Tidsramme: Through study completion, an average of 18 months
|
Through study completion, an average of 18 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026-06
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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