Elderly VolunteersFIFTY+NCT05972590
Characterization of Fecal Microbiota in a Population Aged 50 to 75 Years Targeted by Seasonal Vaccination
A study testing Biological samples collection (blood + feces) in people with Elderly Volunteers, run by Bioaster at 1 site in France.
Trial summary
The goal of this interventional study is to constitute a biological samples collection collected from healthy elderly volunteers and used for scientific purposes. The main questions it aims to answer are: Improving knowledge of the composition of the gut microbiota Identify, isolate and culture microbiota species of… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Volunteers
- What is being tested?
- Biological samples collection (blood + feces)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged between 50 and 75,
- BMI between 18.5 and 29 kg/m2,
- Normal clinical examination,
- Written consent obtained
Who cannot join
- 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)
- Infectious gastrointestinal event within 3 months prior to inclusion
- Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart or liver or biliary disorders, arthritis) or severe chronic disease deemed incompatible with the conduct of the study by the investigator
- Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months prior to inclusion
- Recent food allergy < 3 months prior to inclusion
- Antibiotic, antiviral, antifungal, proton pump inhibitor or any other treatment likely to disrupt the microbiota in the 3 months prior to inclusion
Show all 18Show fewer
- Previous or current use of a treatment that may disrupt the microbiota (e.g. laxatives, antidiarrheals, antacids...) in the last 3 months
- Significant change in dietary habits or physical activities in the 3 months prior to inclusion
- Consumption of more than 2 standard glasses of alcoholic beverages per day
- Smoking > 20 cigarettes per day, illicit drug use,
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Severe psychiatric or neurological pathology
- Subject with liquid stools (Bristol Score = 7) or very hard stools (Bristol Score = 1)
- Any vaccination in the last month before inclusion
- Subject unable to understand the purpose of the research, answer questions and give their decision to participate in the study
- Subject already included in another research study involving the human subject
- Subject under guardianship and whose guardianship objects to the participation of his/her protectee,
- Subject not affiliated with a social security plan or not a beneficiary of such a plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, With Minimal Risks and Constraints Study Aiming at Constituting a Biological Samples Collection Constituted From Volunteers Aged Between 50 and 75 Years Old And Used For Scientific Purposes
The goal of this interventional study is to constitute a biological samples collection collected from healthy elderly volunteers and used for scientific purposes.
The main questions it aims to answer are:
- Improving knowledge of the composition of the gut microbiota
- Identify, isolate and culture microbiota species of interest in the field of health ageing or used as therapeutics associated to the vaccination
- Determining the correlation between the gut microbiota composition and the immune response of individuals.
Read the detailed description
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest.
However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species.
In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.
The goal of this study is to constitute a biological samples collection from elderly people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.
BIOASTER's objective is to strengthen technological support, provide new knowledges and tools for the development of next-generation products. Numerous biotherapeutics companies will benefit from this pipeline, ultimately improving the chances of survival in life-threatening diseases with unmet medical needs.
Elderly people will be recruited by the investigational unit Biofortis.
Blood (Whole blood + TruCulture tubes) and feces will be collected from each volunteer.
- Conditions
- Elderly Volunteers
- Being tested
- Biological samples collection (blood + feces)
- Keywords
- Biobank, Health Ageing, Blood, TruCultures, Stools, Strain isolation, Probiotics, Immunity, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collection (blood + feces)Other
Blood + stools samples will be collected from each volunteer
| Study group | Role | What they receive |
|---|---|---|
| 50-75 years old volunteers cohort | Other | Biological samples collection Blood drawing + faeces collection Receives: Other: Biological samples collection (blood + feces) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and ratio of participants with per protocol collection of blood and feces
Number of volunteers included in the study and number blood/feces pairs collected.
Measured: Baseline
Total number of bacteria strains collected
Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.
Measured: Baseline
Fecal microbiome richness as assessed by alpha diversity
Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)
Measured: Baseline
Secondary outcomes (2)
Immunophenotyping of volunteers as assessed by cytokines quantification
serum samples will be analyzed by ELISA method to quantify cytokines
Measured: Baseline
Immunophenotyping of volunteers as assessed by flow cytometry on immune cells
peripheral blood mononuclear cells will be stained with specific markers antibodies to characterize immune cells populations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start25 Jul 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaster
- Sponsor type
- University, hospital or other
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Cyril GUYARD, Study director, BioasterStéphanie CAVIGIOLI, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972590
- Sponsor's protocol ID
- 2023-A00947-38
- Acronym
- FIFTY+
- Status last verified
- Mar 2024
- First submitted
- 10 Jul 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, With Minimal Risks and Constraints Study Aiming at Constituting a Biological Samples Collection Constituted From Volunteers Aged Between 50 and 75 Years Old And Used For Scientific Purposes
- ClinicalTrials.gov ID
- NCT05972590
- Acronym / sponsor ID
- FIFTY+ / 2023-A00947-38
- Conditions
- Elderly Volunteers
- Keywords
- Biobank, Health Ageing, Blood, TruCultures, Stools, Strain isolation, Probiotics, Immunity, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioasterUniversity, hospital or other
- Collaborators
- BioFortis
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 2 Aug 2023 (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.
The goal of this interventional study is to constitute a biological samples collection collected from healthy elderly volunteers and used for scientific purposes.
The main questions it aims to answer are:
- Improving knowledge of the composition of the gut microbiota
- Identify, isolate and culture microbiota species of interest in the field of health ageing or used as therapeutics associated to the vaccination
- Determining the correlation between the gut microbiota composition and the immune response of individuals.
Detailed description
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest.
However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species.
In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.
The goal of this study is to constitute a biological samples collection from elderly people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.
BIOASTER's objective is to strengthen technological support, provide new knowledges and tools for the development of next-generation products. Numerous biotherapeutics companies will benefit from this pipeline, ultimately improving the chances of survival in life-threatening diseases with unmet medical needs.
Elderly people will be recruited by the investigational unit Biofortis.
Blood (Whole blood + TruCulture tubes) and feces will be collected from each volunteer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50-75 years old volunteers cohort | Other | Other: Biological samples collection (blood + feces)Biological samples collection Blood drawing + faeces collection |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged between 50 and 75,
- BMI between 18.5 and 29 kg/m2,
- Normal clinical examination,
- Written consent obtained
Key exclusion criteria (18 listed)
- 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)
- Infectious gastrointestinal event within 3 months prior to inclusion
- Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart or liver or biliary disorders, arthritis) or severe chronic disease deemed incompatible with the conduct of the study by the investigator
- Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months prior to inclusion
- Recent food allergy < 3 months prior to inclusion
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 samples collection (blood + feces)Blood + stools samples will be collected from each volunteer | Other | 50-75 years old volunteers cohort |
Primary outcome
Number and ratio of participants with per protocol collection of blood and feces
Time frame: Baseline
Number of volunteers included in the study and number blood/feces pairs collected.
Total number of bacteria strains collected
Time frame: Baseline
Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.
Fecal microbiome richness as assessed by alpha diversity
Time frame: Baseline
Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)
2 secondary outcomes
Immunophenotyping of volunteers as assessed by cytokines quantification
Time frame: Baseline
Immunophenotyping of volunteers as assessed by flow cytometry on immune cells
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Cyril GUYARD study director
Bioaster
Stéphanie CAVIGIOLI principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples collection (blood + feces) in people with Elderly Volunteers, run by Bioaster at 1 site in France.
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 18 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: finished, as of the sponsor's last update on 19 Mar 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and ratio of participants with per protocol collection of blood and feces (time frame: Baseline). The study lists 3 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 19 Mar 2024.