Clinical trial NCT06166810: Capture of Healthy Gut Bacteria Associated to High Fiber Diet
Official title: In Silico and in Vitro Targeting of Healthy Gut Bacteria With Fiber Degrading Metabolic Potential
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Population
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2023-12-12
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population residing in Clermont-Ferrand (France)

Brief summary: The role of the intestinal microbiota on health is now well recognised, and diet is one of the factors influencing the maintenance of a healthy intestinal microbiota. More specifically, the consumption of fruit, vegetables and cereals is associated with good health and, in particular, with an increase in the relative abundance of bacterial groups described as beneficial. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterisation of their potential health benefits. In order to isolate and cultivate these intestinal bacteria, it is particularly relevant to recruit individuals with a high-fibre diet.

Detailed description: Since two decades, numerous studies have been performed to better understand the role of the gut microbiota in health and disease. An imbalance in the intestinal microbiota, known as dysbiosis, is frequently described as a cause of many chronic diseases and metabolic dysfunctions in humans. Among the factors that play an important role in maintaining this balance, diet plays a predominant role. More specifically, the consumption of fruit, vegetables and cereals is associated with good health and, in particular, with an increase in the relative abundance of bacterial groups described as beneficial. Modulating the intestinal microbiota via the or directly by providing these beneficial bacteria (next generation probiotics NGPs) is therefore a possible promising approach for the prevention and/or treatment of pathologies. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterization of their potential health benefits. Having strains that can be isolated and cultured is an essential step in phenotyping and characterization. In order to isolate and cultivate these intestinal bacteria, it is particularly important to recruit individuals with a high-fiber diet. In this context, a positive selection of donors, based on their dietary profiles highly enriched in fiber, is essential. In this study, we aim to identify in silico unprecedented potentially new beneficial gut bacteria, and isolate, culture and characterize these bacterial species for their potential. We will take an innovative approach, using culturomics tools guided by metagenomics to isolate them. To do this, we will collect the fecal samples of 10 healthy volunteers with a regular and diversified intake of fruit, vegetables and cereals, which encourage the growth of beneficial micro-organisms and increase the richness of the intestinal microbiota.

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects ;
* Age between 20 and 50 (limits included) ;
* BMI between 18.5 and 25 kg/m2 (excluding limits) ;
* Consumption of more than 5 portions of fruit and vegetables a day;
* Intake of at least 25g of dietary fibre per day;
* A varied diet with little processed food.

Exclusion Criteria:

* Antibiotics and/or transit modulators taken in the 3 months prior to sampling;
* Known pathologies;
* Current treatment;
* History of digestive surgery having an impact on the microbiota, deemed incompatible with the study (bariatric surgery);
* Consumption of food supplements based on protein preparations, probiotics or prebiotics;
* Smoking (even occasionally);
* Alcohol consumption \> 2 glasses (i.e. 20 g) per day;
* Intense sporting activity;
* Pregnant or breast-feeding women;
* Persons under legal protection (curatorship, guardianship, etc.);
* Volunteers taking part in another intervention study;
* Persons refusing to be registered on the French Ministry of Health's Fichier National des Volontaires Sains (National Register of Healthy Volunteers);
* Subject not affiliated to the social security system;
* Subject in a period of exclusion from a previous study or having received a total amount of compensation exceeding 6000 euros over the 12 consecutive months prior to the start of the trial (after verification in the Fichier des Volontaires pour la Recherche Biomédicale).

Primary outcomes:
measure: Primary Outcome
timeFrame: Up to 3 years
Secondary outcomes:
measure: Secondary Outcome 1
timeFrame: Up to 3 years
measure: Secondary Outcome 2
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CRNH Auvergne
Study officials:
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Victoria MESLIER, PhD
role: STUDY_DIRECTOR
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Claire CHERBUY, PhD
role: STUDY_DIRECTOR
References: