Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05323357

Bern Human Organoid-Study to Study Host-microbe Interaction

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-11

100

Participants Needed

1

Research Sites

208 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

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.

CONDITIONS

Official Title

Bern Human Organoid-Study to Study Host-microbe Interaction

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Disease known to chronically affect gut microbiota, gut epithelium or gut-associated immune system, including 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 such as corticoids or biological therapy
  • Current diagnosis of hematological disorders like anemia with hemoglobin below 7 g/dl or leukemia, or any absolute contraindication for blood draw
  • Women who are pregnant
  • Serious coagulation disorders, relevant thrombocytopenia (below 50,000/ul), double platelet-inhibition, oral anticoagulation (except ASS therapy)
  • Known or suspected non-compliance, drug, or alcohol abuse
  • Inability to follow study procedures due to language problems, psychological disorders, dementia, etc.
  • Previous enrollment in the current study
  • Enrollment of investigators, their family members, employees, or other dependent persons
  • Inability or unwillingness to provide blood and tissue biopsy samples
  • Participants taking oral anticoagulants or with bleeding disorders that increase risk after biopsy or contraindicate endoscopy
  • Patients unable to give informed consent
  • Recent antibiotic therapy within the last 4 weeks
  • Participation in other clinical studies interfering with this study's procedures
  • Participants unwilling to be informed about incidental health-relevant findings during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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.

CONTACT

S

Sandro Christensen

CONTACT

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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