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

NCT ID: NCT05972590

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2023-12-15

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.

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.

Conditions

Elderly Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

50-75 years old volunteers cohort

Biological samples collection Blood drawing + faeces collection

Group Type: OTHER

Biological samples collection (blood + feces)

Intervention Type: OTHER

Blood + stools samples will be collected from each volunteer

Interventions

Biological samples collection (blood + feces)

Blood + stools samples will be collected from each volunteer

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Bioaster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyril GUYARD

Role: STUDY_DIRECTOR

Bioaster

Stéphanie CAVIGIOLI

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

Biofortis

Paris, , France

Countries

France

Other Identifiers

2023-A00947-38

Identifier Type: -

Identifier Source: org_study_id