Adults 20 to 80 YearsBOOST-MiNCT07198984
Boosting Microbiota Butyrate Producers to Improve Gut Health
An observational study of Adults 20 to 80 Years, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The human gut microbiota is a dynamic ecosystem essential to health, influenced by diet, age, and lifestyle. It plays a key role in digestion, immunity, and nervous system regulation. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults 20 to 80 Years
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2025to Nov 2028
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- People between the ages of 20 and 80, in good health, with a body mass index between 18.5 kg/m² and 30 kg/m², who are not deprived of their liberty or under guardianship.
- Additional criteria for people aged between 20 and 60: Engaging in sports at least twice a week or following a flexitarian diet, No known chronic conditions, Not undergoing chronic treatment.
Who cannot join
- Under the age of 20 or over the age of 80, Part of the principal investigator's team, Reporting to the investigator (intern, student, or employee under their authority), Having been on antibiotic therapy in the 3 months prior to sampling, Having taken probiotics in the 15 days prior to sampling, Having taken synbiotics in the 15 days prior to sampling, Having a BMI below 18.5 kg/m² or above 30 kg/m², Being deprived of liberty or under guardianship.
- Additional criteria for people aged between 20 and 60: Not exercising twice a week or following a flexitarian diet, Having a chronic illness, Undergoing chronic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ELISE BOREZEE, PhD contact
France1 site, 1 recruiting
- Recruiting
INRAE
Jouy-en-Josas, 78350
REBECA MARTIN ROSIQUE, PhD, 00 33 1 34 65 20 98, rebeca.martin-rosique@inrae.fr
About this study
Official title: Isolate and Characterise Probiotics Capable of Increasing Butyrate Production in Order to Develop Products That Improve Gut Health and Microbiota Balance
The human gut microbiota is a dynamic ecosystem essential to health, influenced by diet, age, and lifestyle. It plays a key role in digestion, immunity, and nervous system regulation. Among its important compounds, short-chain fatty acids, particularly butyrate, are crucial for intestinal and metabolic balance, as they support homeostasis, strengthen the epithelial barrier, and have anti-inflammatory effects.
An imbalance in the microbiota, especially a decrease in butyrate-producing bacteria, is linked to intestinal, metabolic, and neurological disorders. A fiber-rich diet promotes the growth of these beneficial bacteria.
This study aims to isolate and characterize probiotics that can enhance butyrate production, thereby improving intestinal health and microbiota balance. Sampling conditions will comply with regulations governing research involving human subjects.
Read the detailed description
The human gut microbiota is a complex and adaptable ecosystem closely linked to its host, influenced by factors such as diet, lifestyle, and age. It plays key roles in nutrition, immunity, and pathogen protection by breaking down otherwise indigestible fibers into short-chain fatty acids, which are essential for energy production, metabolism, and immune balance.
Butyrate, the best-studied short-chain fatty acids, provides most of the energy for colonic cells, strengthens the intestinal barrier, reduces inflammation, and regulates gene expression related to cell growth, apoptosis, and autophagy. A decrease in butyrate-producing bacteria has been associated with intestinal, metabolic, neurological, and other diseases, including rheumatoid arthritis and fatty liver disease.
Maintaining a healthy microbiota-particularly through a fiber-rich diet that supports butyrate producers-is essential for digestion, nutrient absorption, immune regulation, and overall health, highlighting the strategic role of butyrate in disease prevention and well-being.
This project hypothesizes that increasing microbiota-derived butyrate could improve gut health. Its aim is to isolate and characterize probiotic strains capable of boosting butyrate production, in order to develop scientifically grounded, high-functionality probiotic products. The study will also assess whether butyrate production correlates with beneficial in vitro effects and further clarify how butyrate producers interact with both the microbiota and the host.
- Conditions
- Adults 20 to 80 Years
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacterial strains identified from stool samples that belong to species known to produce butyrate or stimulate butyrate production (16S rRNA gene sequencing)
Stool samples will be collected from participants and processed under anaerobic conditions to maximize bacterial survival. Homogenized samples will be plated on selective culture media and incubated at 37 °C under aerobic or anaerobic conditions. Clones will be expanded in liquid culture, and isolated bacterial strains will be identified by 16S rRNA gene sequencing. The outcome will be reported as the number of distinct strains belonging to species with documented butyrate-producing capacity. The primary endpoint is the identification of at least 12 such strains.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start24 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults 20 to 80 YearsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198984
- Sponsor's protocol ID
- 2025-00623-46
- Other IDs
- 2025
- Acronym
- BOOST-Mi
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolate and Characterise Probiotics Capable of Increasing Butyrate Production in Order to Develop Products That Improve Gut Health and Microbiota Balance
- ClinicalTrials.gov ID
- NCT07198984
- Acronym / sponsor ID
- BOOST-Mi / 2025-00623-46
- Conditions
- Adults 20 to 80 Years
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Sep 2025 (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 human gut microbiota is a dynamic ecosystem essential to health, influenced by diet, age, and lifestyle. It plays a key role in digestion, immunity, and nervous system regulation. Among its important compounds, short-chain fatty acids, particularly butyrate, are crucial for intestinal and metabolic balance, as they support homeostasis, strengthen the epithelial barrier, and have anti-inflammatory effects.
An imbalance in the microbiota, especially a decrease in butyrate-producing bacteria, is linked to intestinal, metabolic, and neurological disorders. A fiber-rich diet promotes the growth of these beneficial bacteria.
This study aims to isolate and characterize probiotics that can enhance butyrate production, thereby improving intestinal health and microbiota balance. Sampling conditions will comply with regulations governing research involving human subjects.
Detailed description
The human gut microbiota is a complex and adaptable ecosystem closely linked to its host, influenced by factors such as diet, lifestyle, and age. It plays key roles in nutrition, immunity, and pathogen protection by breaking down otherwise indigestible fibers into short-chain fatty acids, which are essential for energy production, metabolism, and immune balance.
Butyrate, the best-studied short-chain fatty acids, provides most of the energy for colonic cells, strengthens the intestinal barrier, reduces inflammation, and regulates gene expression related to cell growth, apoptosis, and autophagy. A decrease in butyrate-producing bacteria has been associated with intestinal, metabolic, neurological, and other diseases, including rheumatoid arthritis and fatty liver disease.
Maintaining a healthy microbiota-particularly through a fiber-rich diet that supports butyrate producers-is essential for digestion, nutrient absorption, immune regulation, and overall health, highlighting the strategic role of butyrate in disease prevention and well-being.
This project hypothesizes that increasing microbiota-derived butyrate could improve gut health. Its aim is to isolate and characterize probiotic strains capable of boosting butyrate production, in order to develop scientifically grounded, high-functionality probiotic products. The study will also assess whether butyrate production correlates with beneficial in vitro effects and further clarify how butyrate producers interact with both the microbiota and the host.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (2 listed)
- People between the ages of 20 and 80, in good health, with a body mass index between 18.5 kg/m² and 30 kg/m², who are not deprived of their liberty or under guardianship.
- Additional criteria for people aged between 20 and 60: Engaging in sports at least twice a week or following a flexitarian diet, No known chronic conditions, Not undergoing chronic treatment.
Key exclusion criteria (2 listed)
- Under the age of 20 or over the age of 80, Part of the principal investigator's team, Reporting to the investigator (intern, student, or employee under their authority), Having been on antibiotic therapy in the 3 months prior to sampling, Having taken probiotics in the 15 days prior to sampling, Having taken synbiotics in the 15 days prior to sampling, Having a BMI below 18.5 kg/m² or above 30 kg/m², Being deprived of liberty or under guardianship.
- Additional criteria for people aged between 20 and 60: Not exercising twice a week or following a flexitarian diet, Having a chronic illness, Undergoing chronic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bacterial strains identified from stool samples that belong to species known to produce butyrate or stimulate butyrate production (16S rRNA gene sequencing)
Time frame: up to 3 years
Stool samples will be collected from participants and processed under anaerobic conditions to maximize bacterial survival. Homogenized samples will be plated on selective culture media and incubated at 37 °C under aerobic or anaerobic conditions. Clones will be expanded in liquid culture, and isolated bacterial strains will be identified by 16S rRNA gene sequencing. The outcome will be reported as the number of distinct strains belonging to species with documented butyrate-producing capacity. The primary endpoint is the identification of at least 12 such strains.
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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.
ELISE BOREZEE, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults 20 to 80 Years, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 2 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 16 Dec 2025. 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?
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 REBECA MARTIN ROSIQUE, PhD (00 33 1 34 65 20 98, rebeca.martin-rosique@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bacterial strains identified from stool samples that belong to species known to produce butyrate or stimulate butyrate production (16S rRNA gene sequencing) (time frame: up to 3 years). 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 16 Dec 2025.