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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization
• Intervention / Treatment: Other: Collection of microbiome samples

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Vereecke, PhD; Phone Number: 09/332.64.04; Email: Lars.Vereecke@UGent.be
• Study Contact Backup: Name: Marie Thorp, Master; Phone Number: +32471253213; Email: Marie.Thorp@UGent.be

Study Locations

• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Recruiting
      • Ghent University
      • Contact: Lars Vereecke, PhD; Phone Number: 09/332.64.04; Email: Lars.Vereecke@UGent.be
      • Contact: Marie Thorp, Master; Phone Number: +32471253213; Email: Marie.Thorp@UGent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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. No treatments will be given to the healthy volunteers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Bruno Verhasselt, MD-PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: ONZ-2023-0659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be collected in a pseudonymised database (spreadsheet), the link to the participant's identity is maintained separately from the study data. This pseudonymised data may be shared with other researchers, however, the link to the participan's identity will only be known by the PI and research team of Prof. Lars Vereecke.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No