OrganoidDuoDenOrgNCT07828665
Development of a Duodenal Organoid Model for Host-Intestinal Pathogen Interaction Studies
A study testing Donation of residual biological samples for the development of duodenal organoids. in people with Organoid and Model Disease, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organoid, Model Disease
- What is being tested?
- Donation of residual biological samples for the development of duodenal organoids.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Absence of informed written consent
- Inadequate amount of histologically normal duodenal tissue
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Verona, 37024
Michela Deiana, Dr., +39 0456013311, michela.deiana@sacrocuore.it
About this study
Official title: 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.
- Conditions
- Organoid, Model Disease
- Being tested
- Donation of residual biological samples for the development of duodenal organoids.
- Keywords
- Organoid, In vitro model, pathogen interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients subjected to surgical removal of a portion of the duodenum for clinical indications | Other | Not described Receives: Other: Donation of residual biological samples for the development of duodenal organoids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start9 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrganoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828665
- Sponsor's protocol ID
- 2026-06
- Acronym
- DuoDenOrg
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an in Vitro Model Based on Human Duodenal Organoids for the Study of Host-Intestinal Pathogen Interactions
- ClinicalTrials.gov ID
- NCT07828665
- Acronym / sponsor ID
- DuoDenOrg / 2026-06
- Conditions
- Organoid, Model Disease
- Keywords
- Organoid, In vitro model, pathogen interactions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Absence of informed written consent
- Inadequate amount of histologically normal duodenal tissue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Patients subjected to surgical removal of a portion of the duodenum for clinical indications |
Primary outcome
Successful generation of stable and expandable human duodenal organoids from duodenal tissue
Time frame: Through study completion, an average of 18 months
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donation of residual biological samples for the development of duodenal organoids. in people with Organoid and Model Disease, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo, Dr. (+39 0456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful generation of stable and expandable human duodenal organoids from duodenal tissue (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.