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

NCT06466707 | Recruiting

• 1 other identifier: ONZ-2023-0659
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

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. No treatments will be given to the healthy volunteers.

Other: Collection of microbiome samples

Interventions

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.

Collection of microbiome samples

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Age between 2 and 70 years old
• Dutch speaking
• West-European origin

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Verhasselt, MD-PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Vereecke, PhD

CONTACT

09/332.64.04; Lars.Vereecke@UGent.be

Marie Thorp, Master

CONTACT

+32471253213; Marie.Thorp@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 20, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

BE (1)