Characterization of Fecal Microbiota in a Population Aged 50 to 75 Years Targeted by Seasonal Vaccination (FIFTY+)

Interventional, With Minimal Risks and Constraints Study Aiming at Constituting a Biological Samples Collection Constituted From Volunteers Aged Between 50 and 75 Years Old And Used For Scientific Purposes

The goal of this interventional study is to constitute a biological samples collection collected from healthy elderly volunteers and used for scientific purposes.

The main questions it aims to answer are:

• Improving knowledge of the composition of the gut microbiota
• Identify, isolate and culture microbiota species of interest in the field of health ageing or used as therapeutics associated to the vaccination
• Determining the correlation between the gut microbiota composition and the immune response of individuals.

Study Overview

• Status: Completed
• Conditions: Elderly Volunteers
• Intervention / Treatment: Other: Biological samples collection (blood + feces)

Detailed Description

The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest.

However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species.

In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.

The goal of this study is to constitute a biological samples collection from elderly people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.

BIOASTER's objective is to strengthen technological support, provide new knowledges and tools for the development of next-generation products. Numerous biotherapeutics companies will benefit from this pipeline, ultimately improving the chances of survival in life-threatening diseases with unmet medical needs.

Elderly people will be recruited by the investigational unit Biofortis.

Blood (Whole blood + TruCulture tubes) and feces will be collected from each volunteer.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen LOUIS; Phone Number: +33 6 34 45 23 34; Email: karen.louis@bioaster.org
• Study Contact Backup: Name: Benoît LEVAST; Phone Number: +33 6 60 90 79 42; Email: benoit.levast@bioaster.org

Study Locations

• France
  • Paris, France, 75012
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects aged between 50 and 75,
• BMI between 18.5 and 29 kg/m2,
• Normal clinical examination,
• Written consent obtained

Exclusion Criteria:

• Diagnosed acute or chronic gastrointestinal disease or complication (e.g., celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome)
• Infectious gastrointestinal event within 3 months prior to inclusion
• Severe chronic disease (active cancer, HIV, severe renal failure, ongoing severe heart or liver or biliary disorders, arthritis) or severe chronic disease deemed incompatible with the conduct of the study by the investigator
• Major surgical procedure likely to disrupt the intestinal microbiota, within 6 months prior to inclusion
• Recent food allergy < 3 months prior to inclusion
• Antibiotic, antiviral, antifungal, proton pump inhibitor or any other treatment likely to disrupt the microbiota in the 3 months prior to inclusion
• Previous or current use of a treatment that may disrupt the microbiota (e.g. laxatives, antidiarrheals, antacids...) in the last 3 months
• Significant change in dietary habits or physical activities in the 3 months prior to inclusion
• Consumption of more than 2 standard glasses of alcoholic beverages per day
• Smoking > 20 cigarettes per day, illicit drug use,
• Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
• Severe psychiatric or neurological pathology
• Subject with liquid stools (Bristol Score = 7) or very hard stools (Bristol Score = 1)
• Any vaccination in the last month before inclusion
• Subject unable to understand the purpose of the research, answer questions and give their decision to participate in the study
• Subject already included in another research study involving the human subject
• Subject under guardianship and whose guardianship objects to the participation of his/her protectee,
• Subject not affiliated with a social security plan or not a beneficiary of such a plan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 50-75 years old volunteers cohort; Biological samples collection Blood drawing + faeces collection	Other: Biological samples collection (blood + feces); Blood + stools samples will be collected from each volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and ratio of participants with per protocol collection of blood and feces	Number of volunteers included in the study and number blood/feces pairs collected.	Baseline
Total number of bacteria strains collected	Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.	Baseline
Fecal microbiome richness as assessed by alpha diversity	Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunophenotyping of volunteers as assessed by cytokines quantification	serum samples will be analyzed by ELISA method to quantify cytokines	Baseline
Immunophenotyping of volunteers as assessed by flow cytometry on immune cells	peripheral blood mononuclear cells will be stained with specific markers antibodies to characterize immune cells populations	Baseline

Collaborators and Investigators

• Sponsor: Bioaster
• Collaborators: BioFortis
• Investigators: Study Director: Cyril GUYARD, Bioaster; Principal Investigator: Stéphanie CAVIGIOLI, Biofortis

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Biobank; Immunity; Vaccination; Health Ageing; Blood, TruCultures; Stools; Strain isolation
• Other Study ID Numbers: 2023-A00947-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No