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RecruitingNCT07198984BOOST-MiUpdated Dec 16, 2025

Boosting Microbiota Butyrate Producers to Improve Gut Health

An observational study in Adults 20 to 80 Years, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Recruiting at 1 site in France. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
20 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Adults 20 to 80 Years
03

In context

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 47 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

General population

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07198984
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Nov 24, 2025
Primary completion
Nov 2028 (estimated)
Completion
Nov 2028 (estimated)
Last update
Dec 16, 2025

Study contacts

REBECA MARTIN ROSIQUE, PhD
Contact
rebeca.martin-rosique@inrae.fr
00 33 1 34 65 20 98
ELISE BOREZEE, PhD
Contact
elise.borezee@inrae.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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