Study of human organoids to understand host-microbe interactions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.