Study of human organoids to understand host-microbe interactions
Establishment of Human Organoid Lines as a Tool to Dissect Molecular Pathways of Host-microbiota Interactions
This study is trying to see how the tiny organisms in our gut interact with our body by using samples from people getting endoscopies to grow mini versions of their intestines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05323357 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the complex interactions between human microbiota and the host by establishing organoid cultures derived from the large and small intestine. Participants undergoing upper or lower endoscopic procedures will provide samples, which will be analyzed for transcriptomic, epigenetic, and immunological responses to microbial exposure. The study utilizes standardized protocols for organoid culture and ensures high-quality data collection through the Redcap database. The findings could help translate animal research into human applications, enhancing our understanding of microbiota's role in health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who are scheduled for an endoscopic procedure and meet specific health criteria.
Not a fit: Patients with chronic gut diseases or those on immunosuppressive medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of how microbiota affects human health, potentially guiding new therapeutic strategies.
How similar studies have performed: While many studies have explored microbiota in animal models, this approach using human organoids is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- Inselspital, University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stephanie Ganal-Vonarburg, Prof — Inselspital, University Hospital Bern
- Study coordinator: Stephanie Ganal-Vonarburg, Prof. Dr.
- Email: bauchzentrum@insel.ch
- Phone: +41 31 632 59 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.