Establishment and Culture of Human Intestinal Organoids Derived from Adult Stem Cells.
Cayetano Pleguezuelos-Manzano, Jens Puschhof, Stieneke van den Brink...
https://pubmed.ncbi.nlm.nih.gov/32940424Actively Recruiting
Age: 18Years - 80Years
All Genders
ID05323357
Establishment of Human Organoid Lines to Study Molecular Pathways of Host-Microbiota Interactions
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-11
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the complex communities of microbes that live on and inside the human body, called the microbiota, which can greatly affect human health. Since most microbiota studies have been done on animals due to ethical limits in humans, this research aims to better understand how these findings apply to people. By using human intestinal organoid cultures exposed to microbes and their products, the study seeks to uncover detailed molecular interactions between the microbiota, body tissues, and the immune system. The study involves establishing standardized human organoid cultures from both the large and small intestines, following published protocols. These cultures will be examined using advanced techniques to analyze their gene activity and epigenetic changes after exposure to microbes. There are no intervention groups, as this is an observational study focusing on tissue culture and molecular analysis over a period of three years. Participants will provide tissue samples during medically indicated endoscopic procedures, with data carefully recorded in a secure database. Researchers will assess changes in the transcriptomic and epigenomic profiles of epithelial cells, as well as stem cell maintenance and cell differentiation related to host-microbiota interactions. The study also includes secondary measures involving innovative culture systems to mimic the gut environment. Participant involvement includes consent, sample collection, and follow-up assessments over the study duration until 2026.
CONDITIONS
Brief Title
Bern Human Organoid-Study to Study Host-microbe Interaction
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Scheduled for an upper or lower endoscopic procedure
- Able to understand and follow study procedures and informed consent
- Aged between 18 and 80 years
- Negative pregnancy test for female participants before enrollment
- Body mass index (BMI) between 18.5 and 30 kg/m2
You will not qualify if you...
- Chronic diseases affecting gut microbiota, gut lining, or gut immune system such as inflammatory bowel disease, diverticulitis, microscopic colitis, liver cirrhosis, digestive tract cancers, systemic sclerosis, celiac disease, common-variable immunodeficiency, or diabetes mellitus
- Use of immunosuppressant medications like corticosteroids or biological therapy
- Current hematological disorders or blood draw contraindications
- Pregnancy
- Serious bleeding disorders or use of oral anticoagulants (except aspirin therapy)
- Known or suspected non-compliance, substance abuse
- Inability to follow study procedures due to language, psychological or cognitive issues
- Previous participation in this study
- Enrollment of study staff, family members, or dependents
- Unwillingness or inability to provide blood and tissue samples
- Recent antibiotic therapy within 4 weeks
- Participation in other interfering clinical studies
- Refusal to be informed about incidental health findings during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day of endoscopic procedure
Participants undergo upper or lower endoscopic procedures to collect tissue and blood samples for organoid culture and analysis.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 3 years
Participants' biological samples are analyzed over time to assess changes in transcriptomic and epigenomic profiles related to host-microbiota interactions.
Visits as needed depending on sample collection schedule
Trial Site Locations
Total: 1 location
1
Inselspital, University Hospital Bern
Bern, Switzerland, 3010
Actively Recruiting
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Research Team
S
Stephanie Ganal-Vonarburg, Prof. Dr.
S
Sandro Christensen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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