NCT05323357 Bern Human Organoid-Study to Study Host-microbe Interaction
| NCT ID | NCT05323357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Organoids |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-03-31 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-03-31 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Stephanie Ganal-Vonarburg, Prof
PRINCIPAL INVESTIGATOR
Inselspital, University Hospital Bern
Frequently Asked Questions
Who can join the NCT05323357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Organoids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05323357 currently recruiting?
Yes, NCT05323357 is actively recruiting participants. Contact the research team at bauchzentrum@insel.ch for enrollment information.
Where is the NCT05323357 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05323357 clinical trial?
NCT05323357 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Stephanie Ganal-Vonarburg, Prof at Inselspital, University Hospital Bern. The trial plans to enroll 100 participants.