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

NCT ID: NCT06466707

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Microbial Colonization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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. No treatments will be given to the healthy volunteers.

Group Type OTHER

Collection of microbiome samples

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Verhasselt, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Ghent University

Ghent, East Flanders, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Lars Vereecke, PhD

Role: CONTACT

09/332.64.04

Marie Thorp, Master

Role: CONTACT

+32471253213

Facility Contacts

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Marie Thorp, Master

Role: primary

+32471253213

Lars Vereecke, PhD

Role: backup

09/332.64.04

Other Identifiers

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ONZ-2023-0659

Identifier Type: -

Identifier Source: org_study_id

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