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

Sponsor

Bioaster (Other)

Overall Status

Recruiting

CT.gov ID

NCT05972590

Collaborator

BioFortis (Other)

Enrollment

Location

Arm

4.7

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Elderly Volunteers	Other: Biological samples collection (blood + feces)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jul 24, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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