BACTERIA ISOLATION FROM STOOLS COLLECTED FROM CENTENARIANS PEOPLE

NCT ID: NCT05701371

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2023-10-18

Brief Summary

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 review of the literature shows that certain species present among centenarians have an interest in maintaining the longevity of these individuals. Numerous studies have shown that the intestinal microbiota of centenarians presents a greater diversity compared to groups of younger subjects as well as an enrichment in certain bacteria such as Akkermansia and Christensenella.

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

Elderly and centenarian people will be recruited in nursing home among the Gerontopole of "Ile de France" network.

Blood (serum + TruCulture tubes) and stools will be collected from each subject.

Conditions

Healthy Aging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Centenarian cohort

Biological samples collection

Intervention Type: OTHER

blood drawing + feces collection in a dedicated device

Interventions

Biological samples collection

blood drawing + feces collection in a dedicated device

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 95 years and older
• BMI between 18.5 and 25 kg/m2
• Clinical exam normal
• Subject agreeing to participate in the study and not objecting to participate in the study.
• Able and willing to provide samples of blood and faeces

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
• Diabetes
• 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
• Completely dependent subject (GIR Score = 1)
• Subject with liquid stools (Bristol Score = 7) or very hard stools (Bristol Score = 1)
• 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: 95 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bioaster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyril GUYARD

Role: STUDY_DIRECTOR

Bioaster

Olivier HANON

Role: PRINCIPAL_INVESTIGATOR

Gérond'if

Locations

Gerond'if - Gérontopôle Ile de France

Paris, , France

Countries

France

Other Identifiers

2022-A02293-40

Identifier Type: -

Identifier Source: org_study_id