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.

Overview

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.

Interventions

• 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.

Primary outcome measures

• Composition of the microbiome, as determined by metagenomics analysis of the skin, oral, vaginal and fecal microbiome samples [Time frame: 4 years]
• Compostition of the metabolome, as deteremined by metabolomics analysis skin, oral, vaginal and fecal microbiome samples [Time frame: 4 years]
• Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by weight measurement [Time frame: 4 years]
• Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by detecting blood in stool [Time frame: 4 years]
• Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by determining stool consistency [Time frame: 4 years]
• Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by serum glucose measurement [Time frame: 4 years]
• Measurement of immune activation upon administration of different microbiota (Western versus indigenous). [Time frame: 4 years]
• Identification of the micro-organisms from different microbiota (Western versus indigenous) linked to disease progression. [Time frame: 4 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Belgium · 1 center

• Ghent University — Ghent

Identifiers

NCT: NCT06466707 · ONZ-2023-0659

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗