Microbial ColonizationNCT06466707
Collection of Microbiome Samples of Healthy Western Donors for Fundamental and Functional Microbiome Research
A study testing Collection of microbiome samples in people with Microbial Colonization, run by University Ghent at 1 site in Belgium.
Trial 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'. Read more about this study
- Who is it for?
- Ages 2 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Collection of microbiome samples
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jun 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy
- Age between 2 and 70 years old
- Dutch speaking
- West-European origin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, East Flanders, 9000
Marie Thorp, Master, +32471253213, Marie.Thorp@UGent.be
Lars Vereecke, PhD, 09/332.64.04, Lars.Vereecke@UGent.be
About this study
Official title: 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.
- Conditions
- Microbial Colonization
- Being tested
- Collection of microbiome samples
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of microbiome samplesOther
Collection of skin, oral and vaginal (if applicable) microbiome samples by means of a swab and collection of fecal material using Fecotainer collection kit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of microbiome samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start4 Jun 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Verhasselt, MD-PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466707
- Sponsor's protocol ID
- ONZ-2023-0659
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collectie Van Microbioomstalen Van Huid, Mond, Vagina en Feces Van Gezonde Westerse Donoren Voor Fundamenteel en Functioneel Microbioom-onderzoek.
- ClinicalTrials.gov ID
- NCT06466707
- Acronym / sponsor ID
- ONZ-2023-0659
- Conditions
- Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of microbiome samples | Other | Other: Collection of microbiome samplesCollection 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. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Age between 2 and 70 years old
- Dutch speaking
- West-European origin
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of microbiome samplesCollection of skin, oral and vaginal (if applicable) microbiome samples by means of a swab and collection of fecal material using Fecotainer collection kit. | Other | Collection of microbiome samples |
Primary outcome
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)
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)
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Verhasselt, MD-PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of microbiome samples in people with Microbial Colonization, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Vereecke, PhD (09/332.64.04, Lars.Vereecke@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the microbiome, as determined by metagenomics analysis of the skin, oral, vaginal and fecal microbiome samples (time frame: 4 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.