Bern Human Organoid-Study to Study Host-microbe Interaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Organoids, Allergy and Immunology, Microbiota. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Establishment of Human Organoid Lines as a Tool to Dissect Molecular Pathways of Host-microbiota Interactions
Overview
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.
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 (Pleguezuelos-Manzano et al. 2020)
Primary outcome measures
- Assessment of changes in the transcriptomic profile of epithelial cells before and after organoid culture [Time frame: 3 Years]
- Assessment of changes in the epigenome of epithelial cells before and after organoid culture [Time frame: 3 Years]
- Transcriptomic and Epigenomic Landscape of host-microbiota Interaction [Time frame: 3 Years]
- Host-Microbiota interaction - Stem cell maintenance and Cell Differentiation [Time frame: 3 Years]
Secondary outcome measures (2)
- 3D-to-2D Transwell System [Time frame: 3 Years]
- Gut-on-a-chip [Time frame: 3 Years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Switzerland · 1 center
- Inselspital, University Hospital Bern — Bern
Publications
- Pleguezuelos-Manzano C, Puschhof J, van den Brink S, Geurts V, Beumer J, Clevers H. Establishment and Culture of Human Intestinal Organoids Derived from Adult Stem Cells. Curr Protoc Immunol. 2020 Sep;130(1):e106. doi: 10.1002/cpim.106. PMID 32940424
Identifiers
NCT: NCT05323357 · 2021-01865