Collection of Microbiome Samples of Healthy Western Donors for Fundamental and Functional Microbiome Research

Microbial Colonization Clinical Trial

Official title:

Collectie Van Microbioomstalen Van Huid, Mond, Vagina en Feces Van Gezonde Westerse Donoren Voor Fundamenteel en Functioneel Microbioom-onderzoek.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466707
• Other study ID #: ONZ-2023-0659
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Lars Vereecke, PhD
• Phone: 09/332.64.04
• Email: Lars.Vereecke[@]UGent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Other:
• Collection of microbiome samples
Collection of skin, oral and vaginal (if applicable) microbiome samples by means of a swab and collection of fecal material using Fecotainer collection kit.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of the microbiome, as determined by metagenomics analysis of the skin, oral, vaginal and fecal microbiome samples	Characterization of skin, oral, vaginal and fecal microbiome profiles from Western donors versus indigenous Brazilian tribes (Yanomami, samples collected previously)	4 years
Primary	Compostition of the metabolome, as deteremined by metabolomics analysis skin, oral, vaginal and fecal microbiome samples	Characterization of skin, oral, vaginal and fecal metabolome profiles from Western donors versus indigenous Brazilian tribes (Yanomami, samples collected previously)	4 years
Primary	Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by weight measurement	Measurement of disease progression in arthritis, colorectal cancer, intestinal inflammation, obesity, etc. by measuring weight loss or gain.	4 years
Primary	Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by detecting blood in stool	Measurement of disease progression in colorectal cancer, intestinal inflammation, etc. by determining presence of blood in stool samples.	4 years
Primary	Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by determining stool consistency	Measurement of disease progression in colorectal cancer, intestinal inflammation, etc. by determining stool consistency.	4 years
Primary	Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by serum glucose measurement	Measurement of disease progression in obesity by measuring serum glucose concentrations.	4 years
Primary	Measurement of immune activation upon administration of different microbiota (Western versus indigenous).	Measurement of immune cell composition by means of flow cytometry analysis.	4 years
Primary	Identification of the micro-organisms from different microbiota (Western versus indigenous) linked to disease progression.	Identification of microorganisms involved in disease models (including arthritis, colorectal cancer, intestinal inflammation, obesity, etc.) by means of in-vitro and in-vivo models. The stool samples are administered to mouse models of various diseases via oral gavage, after which the disease process is closely studied. For the in-vitro models, these samples are used to stimulate cell lines to investigate the effect on, for example, T cell activation, macrophage polarization or general cell proliferation.	4 years