BACTERIA ISOLATION FROM STOOLS COLLECTED FROM CENTENARIANS PEOPLE (BISCOTE)

NON-INTERVENTIONAL STUDY, MULTICENTRIC STUDY, AIMING AT CONSTITUTING A BIOLOGICAL SAMPLES COLLECTION FROM CENTENARIAN PEOPLE

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Biological samples collection

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Gerond'if - Gérontopôle Ile de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 95 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Elderly (>95 years old) and centenarians people

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Centenarian cohort	Other: Biological samples collection; blood drawing + feces collection in a dedicated device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of a bank of blood and faeces biological samples from centenarians people for research purposes	Study will collect up to 18 mL of blood and minimum of 20g of faeces at one visit from people aged > 95 years.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria collection	Isolation and culture of bacteria of interest	One day
Fecal microbiota composition	Measures of alpha and beta diversity of fecal samples	One day
Immuno-modulatory properties of isolated strains	Cellular assays with immune related readout to decipher pro and/or anti inflammatory properties	One day

Collaborators and Investigators

• Sponsor: Bioaster
• Collaborators: Gerond'if (Gerontopole Ile de France)
• Investigators: Study Director: Cyril GUYARD, Bioaster; Principal Investigator: Olivier HANON, Gérond'if

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 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; Observational Study; Blood; Feces; Strain Isolation
• Other Study ID Numbers: 2022-A02293-40

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