Boosting Microbiota Butyrate Producers to Improve Gut Health

NCT07198984 | Recruiting

• 1 other identifier: 2025-00623-46
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adults 20 to 80 Years

Outcome Measures

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.

  up to 3 years

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead

Study Sites (1)

INRAE

Jouy-en-Josas, 78350, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

Central Study Contacts

REBECA MARTIN ROSIQUE, PhD

CONTACT

00 33 1 34 65 20 98; rebeca.martin-rosique@inrae.fr

ELISE BOREZEE, PhD

CONTACT

elise.borezee@inrae.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 30, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)