Capture of Healthy Gut Bacteria Associated to High Fiber Diet

General Population Clinical Trial

— iTARGET  

Official title:

In Silico and in Vitro Targeting of Healthy Gut Bacteria With Fiber Degrading Metabolic Potential

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166810
• Other study ID #: 2023-A01677-38
• Status: Recruiting
• Start date: October 24, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: November 2023
• Source: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
• Contact: Aurélie CAILLE, MSc
• Phone: 04 73 75 42 73
• Email: acaille[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• General Population

Locations

Country	Name	City	State
France	CRNH Auvergne	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement	CRNH Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	The main aim of the study is to isolate bacteria from the faeces of participants on a high-fibre diet (new isolates of known species and new species for which no representatives have yet been isolated).	Up to 3 years
Secondary	Secondary Outcome 1	Characterise the microbiota of individuals to identify carriers of bacteria of interest in relation to their diet	Up to 3 years
Secondary	Secondary Outcome 2	Characterise the bacteria isolated (phenotype and genotype).	Up to 3 years