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NCT Number: NCT06466707

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

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of microbiome samples

Other

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 outcomes

  1. Composition of the microbiome, as determined by metagenomics analysis of the skin, oral, vaginal and fecal microbiome samples

    Time frame: 4 years

    Characterization of skin, oral, vaginal and fecal microbiome profiles from Western donors versus indigenous Brazilian tribes (Yanomami, samples collected previously)

  2. Compostition of the metabolome, as deteremined by metabolomics analysis skin, oral, vaginal and fecal microbiome samples

    Time frame: 4 years

    Characterization of skin, oral, vaginal and fecal metabolome profiles from Western donors versus indigenous Brazilian tribes (Yanomami, samples collected previously)

  3. Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by weight measurement

    Time frame: 4 years

    Measurement of disease progression in arthritis, colorectal cancer, intestinal inflammation, obesity, etc. by measuring weight loss or gain.

  4. 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 in colorectal cancer, intestinal inflammation, etc. by determining presence of blood in stool samples.

  5. Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by determining stool consistency

    Time frame: 4 years

    Measurement of disease progression in colorectal cancer, intestinal inflammation, etc. by determining stool consistency.

  6. Measurement of disease progression upon administration of different microbiota (Western versus indigenous) by serum glucose measurement

    Time frame: 4 years

    Measurement of disease progression in obesity by measuring serum glucose concentrations.

  7. Measurement of immune activation upon administration of different microbiota (Western versus indigenous).

    Time frame: 4 years

    Measurement of immune cell composition by means of flow cytometry analysis.

  8. Identification of the micro-organisms from different microbiota (Western versus indigenous) linked to disease progression.

    Time frame: 4 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Vereecke, PhD

CONTACT

[email protected]

09/332.64.04

Marie Thorp, Master

CONTACT

[email protected]

+32471253213

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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