Bern Human Organoid-Study to Study Host-microbe Interaction
NCT ID: NCT05323357
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-03-31
2026-03-30
Brief Summary
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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
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* Establishment of human organoid cultures are standardized by published protocols (Pleguezuelos-Manzano et al. 2020)
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Bern
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Stephanie Ganal-Vonarburg, Prof
Role: PRINCIPAL_INVESTIGATOR
Inselspital, University Hospital Bern
Locations
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Inselspital, University Hospital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Bauchzentrum
Role: primary
References
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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.
Related Links
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Pleguezuelos-Manzano C et al. 2020
Other Identifiers
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2021-01865
Identifier Type: -
Identifier Source: org_study_id