Biological SamplesHIBISCUSNCT06602388
Human Internal BIOASTER's Samples Collection
An observational study of Biological Samples, run by Bioaster.
Trial summary
BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biological Samples
- What is being tested?
- Biological sampling
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 31 Dec 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers (Bioaster employees)
Who may be able to join
- Some inclusion criteria can be defined according to the needs of the scientific objective. For example, it is up to volunteers to decide whether or not to participate if they meet the following criteria:
- Age criteria (e.g.: specific, non-identifying range sought: 30-40 years)
- BMI criteria (for example: BMI between 18.5 and 29 kg/m2)
- Gender criteria (e.g.: women only)
Who cannot join
- Some of the following non-inclusion criteria may be defined according to the needs of the project:
- Minor subject
- Health criteria (e.g. presence or absence illness/infection/vaccination/allergy/anti-infective treatment in the last 3 months prior to the date of sampling)
- Smoker status
- Severe chronic illness (active cancer, HIV, severe renal failure, ongoing severe heart, liver or biliary disorders, arthritis)
- Diagnosed acute or chronic gastrointestinal disease or complication (e.g. celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn\'s disease, hemorrhoids, irritable bowel syndrome),
Show all 10Show fewer
- In all cases, it will be requested that volunteers with the following criteria do not participate in the study:
- Pregnant or breast-feeding women
- Subjects under curatorship or guardianship
- Subjects under legal protection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-interventional, Monocentric Study Aimed at Building up a Collection of Biological Samples Collected From Bioaster Collaborators for Scientific Purposes
BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics.
Hibiscus is a non-interventional, monocentric study aimed at building up a a collection of biological samples (stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair) collected from BIOASTER employees. These samples to be used for scientific purposes including the technological development of Bioaster s collaborative and in-house research projects.
- Conditions
- Biological Samples
- Being tested
- Biological sampling
- Keywords
- Biological, samples, collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingOther
Collection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers (Bioaster employees) | Collection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of analyzable samples collected for scientific purposes.
The number of analyzable samples collected for scientific purposes at the end of inclusion periode
Measured: 3 years after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological SamplesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioaster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril GUYARD, Study Director, Study director, BioasterDr Xavier MORGE, Principal investigator, Bioaster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602388
- Sponsor's protocol ID
- 2024-A00323-44
- Acronym
- HIBISCUS
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Monocentric Study Aimed at Building up a Collection of Biological Samples Collected From Bioaster Collaborators for Scientific Purposes
- ClinicalTrials.gov ID
- NCT06602388
- Acronym / sponsor ID
- HIBISCUS / 2024-A00323-44
- Conditions
- Biological Samples
- Keywords
- Biological, samples, collection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- BioasterUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 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.
BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics.
Hibiscus is a non-interventional, monocentric study aimed at building up a a collection of biological samples (stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair) collected from BIOASTER employees. These samples to be used for scientific purposes including the technological development of Bioaster s collaborative and in-house research projects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers (Bioaster employees) | – | Other: Biological samplingCollection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers (Bioaster employees)
Key inclusion criteria (4 listed)
- Some inclusion criteria can be defined according to the needs of the scientific objective. For example, it is up to volunteers to decide whether or not to participate if they meet the following criteria:
- Age criteria (e.g.: specific, non-identifying range sought: 30-40 years)
- BMI criteria (for example: BMI between 18.5 and 29 kg/m2)
- Gender criteria (e.g.: women only)
Key exclusion criteria (10 listed)
- Some of the following non-inclusion criteria may be defined according to the needs of the project:
- Minor subject
- Health criteria (e.g. presence or absence illness/infection/vaccination/allergy/anti-infective treatment in the last 3 months prior to the date of sampling)
- Smoker status
- Severe chronic illness (active cancer, HIV, severe renal failure, ongoing severe heart, liver or biliary disorders, arthritis)
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 |
|---|---|---|
| Biological samplingCollection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair | Other | Healthy volunteers (Bioaster employees) |
Primary outcome
The number of analyzable samples collected for scientific purposes.
Time frame: 3 years after the first inclusion
The number of analyzable samples collected for scientific purposes at the end of inclusion periode
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 Sep 2024.
- Individual participant dataSharing planned: No
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Sample Collection
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.
Cyril GUYARD, Study Director study director
Bioaster
Dr Xavier MORGE principal investigator
Bioaster
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Samples, run by Bioaster.
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 10 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: opening soon, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Karima BRAHAMI-AISSOU (+336 34 53 37 84 ext. +33, karima.brahami-aissou@bioaster.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of analyzable samples collected for scientific purposes. (time frame: 3 years after the first inclusion). 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 Sep 2024.