Bern Human Organoid-Study to Study Host-microbe Interaction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
1. Patients undergoing routine ileo-colonoscopy without sign of inflammation, dysplasia, or neoplasia in histology 2. Patients undergoing routine gastro-duodenoscopy without sign of inflammation, dysplasia, or neoplasia in histology
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture
Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture is established by RNA-sequencing and quantitative polymerase chain reaction (qPCR)
Time frame
3 Years2
Assessment of changes in the epigenome of epithelial cells before and after organoid culture
Assessment of changes in the epigenome of epithelial cells before and after organoid culture is established by whole genome bisulphite sequencing and chromatin immunoprecipitation sequencing
Time frame
3 Years3
Transcriptomic and Epigenomic Landscape of host-microbiota Interaction
Determining effects of microbial-derived metabolites on the transcriptomic and epigenomic landscape of human organoids treated with the respective metabolite
Time frame
3 Years4
Host-Microbiota interaction - Stem cell maintenance and Cell Differentiation
Determining effects of microbial-derived metabolites on epithelial cell differentiation and stem cell maintenance
Time frame
3 YearsSecondary outcomes
1
3D-to-2D Transwell System
Establishing a method to transform human organoid culture into a 2-dimensional trans-well system which allows transportation studies, characterization of epithelial integrity and other downstream analysis
Time frame
3 Years2
Gut-on-a-chip
Applying 2-dimensional trans-well system to a gut-on-a-chip set-up in collaboration with the Artorg Center at the University of Bern
Time frame
3 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
Source ClinicalTrials.gov