Clinical trial NCT06466707: Collection of Microbiome Samples of Healthy Western Donors for Fundamental and Functional Microbiome Research
Official title: Collectie Van Microbioomstalen Van Huid, Mond, Vagina en Feces Van Gezonde Westerse Donoren Voor Fundamenteel en Functioneel Microbioom-onderzoek.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Large numbers of micro-organisms (especially bacteria) live in and on human bodies and have a very important function for the health. These microorganisms are called 'the microbiota'. They aid in the digestion of food, ensure the production of certain vitamins, and are very important for the development and regulation of the immune system. In many diseases (including Crohn's disease, arthritis, obesity, diabetes and cancer), a disruption of microbial composition is observed. There are indications that a disruption of the microbiome can contribute to the development of inflammatory diseases and cancer, but the underlying processes are not sufficiently understood. To understand the mechanisms underlying these disease processes, fundamental research is conducted at Ghent University. Stool, skin, oral and vaginal samples from various origins are examined, e.g. from people from indigenous tribes with a traditional lifestyle. It is important that these samples can be compared with microbiome samples from healthy Western (West-European) controls. In this study, the investigators want to build up a collection of samples from healthy donors between the ages of 2 and 70, with the exception of vaginal samples collected from women between the ages of 18 and 45. The samples will form the basis for further fundamental and functional research into microbiota-host interactions at Ghent University.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Age between 2 and 70 years old
* Dutch speaking
* West-European origin

Exclusion Criteria:

* Diagnosis of chronic disease (such as osteoarthritis, rheumatoid arthritis, diabetes, Crohn's disease, inflammatory bowel disease (IBD), asthma, COPD, etc.)
* Antibiotics taken within 3 months before sampling

Primary outcomes:
measure: Composition of the microbiome, as determined by metagenomics analysis of the skin, oral, vaginal and fecal microbiome samples
timeFrame: 4 years
measure: Compostition of the metabolome, as deteremined by metabolomics analysis skin, oral, vaginal and fecal microbiome samples
timeFrame: 4 years
measure: Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by weight measurement
timeFrame: 4 years
measure: Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by detecting blood in stool
timeFrame: 4 years
measure: Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by determining stool consistency
timeFrame: 4 years
measure: Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by serum glucose measurement
timeFrame: 4 years
measure: Measurement of immune activation upon administration of different microbiota (Western versus indigenous).
timeFrame: 4 years
measure: Identification of the micro-organisms from different microbiota (Western versus indigenous) linked to disease progression.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: East Flanders
Study officials:
affiliation: University Ghent
name: Bruno Verhasselt, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: