Image

Bern Human Organoid-Study to Study Host-microbe Interaction

Bern Human Organoid-Study to Study Host-microbe Interaction

Recruiting
18-80 years
All
Phase N/A

Powered by AI

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.

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)

Eligibility

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

Study details
    Organoids
    Allergy and Immunology
    Microbiota

NCT05323357

Insel Gruppe AG, University Hospital Bern

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.