Status:
RECRUITING
Bern Human Organoid-Study to Study Host-microbe Interaction
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Conditions:
Organoids
Allergy and Immunology
Eligibility:
All Genders
18-80 years
Brief 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 ...
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 (Pleg...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05323357
Start Date
March 31 2022
End Date
March 30 2026
Last Update
December 11 2024
Active Locations (1)
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1
Inselspital, University Hospital Bern
Bern, Switzerland, 3010