OrganoidshumorgNCT05323357
Bern Human Organoid-Study to Study Host-microbe Interaction
An observational study of Organoids and Allergy and Immunology, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The human body inhabits a complex consortium of different microbes which together form the microbiota. Virtually every surface of the human body is colonized by a distinct microbiota, forming complex communities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Organoids, Allergy and Immunology, Microbiota
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2022to 30 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients undergoing routine ileo-colonoscopy without sign of inflammation, dysplasia, or neoplasia in histology 2. Patients undergoing routine gastro-duodenoscopy without sign of inflammation, dysplasia, or neoplasia in histology
Who may be able to join
- Signed informed consent
- Indication for upper or lower endoscopic procedure
- Ability to understand and follow study procedures and understand informed consent
- Age 18-80 years
- Negative pregnancy test result prior to study enrollment of female study participants (test will be performed prior to enrollment)
- BMI between 18.5 and 30 kg/m2
Who cannot join
- Disease known to chronically affect gut microbiota, gut epithelium or gut-associated immune system, namely inflammatory bowel disease, diverticulitis, microscopic colitis, liver cirrhosis, malignancy within the digestive tract, systemic sclerosis, coeliac disease, common-variable immunodeficiency, diabetes mellitus
- Medication with immunosuppressants (e.g. corticoids, biological therapy)
- Current diagnosis of a hematological disorder (e.g. anemia with hemoglobin <7 g/dl, leukemia) or any other absolute contraindication for blood draw
- Women who are pregnant
- Serious coagulation disorder, relevant thrombocytopenia (<50'000/ul), double platelet-inhibition, oral anticoagulation (ASS therapy is possible)
- Known or suspected non-compliance, drug, or alcohol abuse
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- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
- Inability or unwillingness to provide blood samples and tissue samples (biopsies)
- Participants taking oral anticoagulant or with bleeding disorders who would be at much higher risk of bleeding after biopsy samples or who are contraindicated for an endoscopic examination
- Patients unable to give informed consent
- Patients that have been under antibiotic therapy in the last 4 weeks
- Participation in other clinical study interfering with study procedures
- Potential study participants that wish not to be informed about random results acquired during the study (e.g., during endoscopy or genetic analysis) relevant for their health and for prevention of diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, University Hospital Bern
Bern, 3010
Bauchzentrum, +41 31 632 59 00, bauchzentrum@insel.ch
Stephanie Ganal-Vonarburg, Prof
About this study
Official title: Establishment of Human Organoid Lines as a Tool to Dissect Molecular Pathways of Host-microbiota Interactions
The human body inhabits a complex consortium of different microbes which together form the microbiota. Virtually every surface of the human body is colonized by a distinct microbiota, forming complex communities. An increasing number of research results indicates that changes in the microbiota can have vast effects on the health of its host.
Most studies investigating the microbiota were conducted on animals, as many interventions and investigations cannot be performed on humans due to ethical considerations. This raises the question if findings from experimental studies are translational and can benefit patients. That becomes especially apparent when trying to dissect molecular mechanisms involved in this fine-tuned interplay between nutrients, the microbiota, and its host.
By establishing human organoid cultures from the large and small intestine that can be exposed to microbes and/or microbial products with subsequent transcriptomic, epigenetic and immunological analysis, the investigators aim to generate findings with high translational potential with new insights into the complex interaction of the microbiota, the host and its immune system.
Read the detailed description
- Data obtained from participants will be recorded in the database Redcap to ensure high-quality data recording
- Establishment of human organoid cultures are standardized by published protocols (Pleguezuelos-Manzano et al. 2020)
- Conditions
- Organoids, Allergy and Immunology, Microbiota
- Keywords
- Enteroids, Host-Microbiota, Mucosal Immunology
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture is established by RNA-sequencing and quantitative polymerase chain reaction (qPCR)
Measured: 3 Years
Assessment of changes in the epigenome of epithelial cells before and after organoid culture
Assessment of changes in the epigenome of epithelial cells before and after organoid culture is established by whole genome bisulphite sequencing and chromatin immunoprecipitation sequencing
Measured: 3 Years
Transcriptomic and Epigenomic Landscape of host-microbiota Interaction
Determining effects of microbial-derived metabolites on the transcriptomic and epigenomic landscape of human organoids treated with the respective metabolite
Measured: 3 Years
Host-Microbiota interaction - Stem cell maintenance and Cell Differentiation
Determining effects of microbial-derived metabolites on epithelial cell differentiation and stem cell maintenance
Measured: 3 Years
Secondary outcomes (2)
3D-to-2D Transwell System
Establishing a method to transform human organoid culture into a 2-dimensional trans-well system which allows transportation studies, characterization of epithelial integrity and other downstream analysis
Measured: 3 Years
Gut-on-a-chip
Applying 2-dimensional trans-well system to a gut-on-a-chip set-up in collaboration with the Artorg Center at the University of Bern
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start31 Mar 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OrganoidsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Stephanie Ganal-Vonarburg, Prof, Principal investigator, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323357
- Sponsor's protocol ID
- 2021-01865
- Acronym
- humorg
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pleguezuelos-Manzano C, Puschhof J, van den Brink S, Geurts V, Beumer J, Clevers H. Establishment and Culture of Human Intestinal Organoids Derived from Adult Stem Cells. Curr Protoc Immunol. 2020 Sep;130(1):e106. doi: 10.1002/cpim.106.
PubMed 32940424
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Human Organoid Lines as a Tool to Dissect Molecular Pathways of Host-microbiota Interactions
- ClinicalTrials.gov ID
- NCT05323357
- Acronym / sponsor ID
- humorg / 2021-01865
- Conditions
- Organoids, Allergy and Immunology, Microbiota
- Keywords
- Enteroids, Host-Microbiota, Mucosal Immunology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Apr 2022 (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 human body inhabits a complex consortium of different microbes which together form the microbiota. Virtually every surface of the human body is colonized by a distinct microbiota, forming complex communities. An increasing number of research results indicates that changes in the microbiota can have vast effects on the health of its host.
Most studies investigating the microbiota were conducted on animals, as many interventions and investigations cannot be performed on humans due to ethical considerations. This raises the question if findings from experimental studies are translational and can benefit patients. That becomes especially apparent when trying to dissect molecular mechanisms involved in this fine-tuned interplay between nutrients, the microbiota, and its host.
By establishing human organoid cultures from the large and small intestine that can be exposed to microbes and/or microbial products with subsequent transcriptomic, epigenetic and immunological analysis, the investigators aim to generate findings with high translational potential with new insights into the complex interaction of the microbiota, the host and its immune system.
Detailed description
- Data obtained from participants will be recorded in the database Redcap to ensure high-quality data recording
- Establishment of human organoid cultures are standardized by published protocols (Pleguezuelos-Manzano et al. 2020)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients undergoing routine ileo-colonoscopy without sign of inflammation, dysplasia, or neoplasia in histology 2. Patients undergoing routine gastro-duodenoscopy without sign of inflammation, dysplasia, or neoplasia in histology
Key inclusion criteria (6 listed)
- Signed informed consent
- Indication for upper or lower endoscopic procedure
- Ability to understand and follow study procedures and understand informed consent
- Age 18-80 years
- Negative pregnancy test result prior to study enrollment of female study participants (test will be performed prior to enrollment)
Key exclusion criteria (15 listed)
- Disease known to chronically affect gut microbiota, gut epithelium or gut-associated immune system, namely inflammatory bowel disease, diverticulitis, microscopic colitis, liver cirrhosis, malignancy within the digestive tract, systemic sclerosis, coeliac disease, common-variable immunodeficiency, diabetes mellitus
- Medication with immunosuppressants (e.g. corticoids, biological therapy)
- Current diagnosis of a hematological disorder (e.g. anemia with hemoglobin <7 g/dl, leukemia) or any other absolute contraindication for blood draw
- Women who are pregnant
- Serious coagulation disorder, relevant thrombocytopenia (<50'000/ul), double platelet-inhibition, oral anticoagulation (ASS therapy is possible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture
Time frame: 3 Years
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture is established by RNA-sequencing and quantitative polymerase chain reaction (qPCR)
Assessment of changes in the epigenome of epithelial cells before and after organoid culture
Time frame: 3 Years
Assessment of changes in the epigenome of epithelial cells before and after organoid culture is established by whole genome bisulphite sequencing and chromatin immunoprecipitation sequencing
Transcriptomic and Epigenomic Landscape of host-microbiota Interaction
Time frame: 3 Years
Determining effects of microbial-derived metabolites on the transcriptomic and epigenomic landscape of human organoids treated with the respective metabolite
Host-Microbiota interaction - Stem cell maintenance and Cell Differentiation
Time frame: 3 Years
Determining effects of microbial-derived metabolites on epithelial cell differentiation and stem cell maintenance
2 secondary outcomes
3D-to-2D Transwell System
Time frame: 3 Years
Gut-on-a-chip
Time frame: 3 Years
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 11 Dec 2024.
- Background: PubMed 32940424Pleguezuelos-Manzano C, Puschhof J, van den Brink S, Geurts V, Beumer J, Clevers H. Establishment and Culture of Human Intestinal Organoids Derived from Adult Stem Cells. Curr Protoc Immunol. 2020 Sep;130(1):e106. doi: 10.1002/cpim.106.
- Pleguezuelos-Manzano C et al. 2020Link provided by the sponsor.
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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.
Stephanie Ganal-Vonarburg, Prof principal investigator
Inselspital, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organoids and Allergy and Immunology, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 inclusion and 15 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 11 Dec 2024. 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 Switzerland. 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 Stephanie Ganal-Vonarburg, Prof. Dr. (+41 31 632 59 00, bauchzentrum@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture (time frame: 3 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323357, which also lists 1 linked publication.
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 11 Dec 2024.