Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05323357
Other study ID # 2021-01865
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 31, 2022
Est. completion date March 30, 2026

Study information

Verified date May 2023
Source University Hospital Inselspital, Berne
Contact Bauchzentrum
Phone +41 31 632 59 00
Email bauchzentrum@insel.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 30, 2026
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Inselspital, University Hospital Bern Bern

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3 Years
Primary 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 3 Years
Primary 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 3 Years
Primary Host-Microbiota interaction - Stem cell maintenance and Cell Differentiation Determining effects of microbial-derived metabolites on epithelial cell differentiation and stem cell maintenance 3 Years
Secondary 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 3 Years
Secondary 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 3 Years
See also
  Status Clinical Trial Phase
Withdrawn NCT03239197 - Project SHARE (motherS Have All the Right microbEs) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Recruiting NCT04138979 - Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy
Recruiting NCT04132713 - Study on Skin Microbiome of HFS
Completed NCT05726435 - Effects of Soluble Dietary Fiber on Sport Efficiency and Fatigue Delay in Top Basketball Players N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Completed NCT03543891 - Intestinal Microbiota and Thyroid Cancer
Completed NCT05242913 - Effects of Resistant Potato Starch on the Gut Microbiota N/A
Recruiting NCT04200521 - The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
Recruiting NCT05891977 - Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults N/A
Completed NCT02988349 - Ecological Effect of Arginine Dentifrice on Oral Microbiota N/A
Completed NCT05352724 - Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise N/A
Completed NCT04674839 - The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals N/A
Completed NCT03754504 - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05394948 - Circular Economy and the Design of Healthy and Sustainable Food and Ingredients N/A
Terminated NCT03752372 - Microbiome Alterations in IL10RA-deficient Patients After HSCT
Completed NCT05974124 - Effectiveness of Ophthalmic Antiseptic Preparations N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A