BACTERIA ISOLATION FROM STOOLS COLLECTED FROM CENTENARIANS PEOPLE

NCT05701371 | Terminated

• 1 other identifier: 2022-A02293-40
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Biobank; Observational Study; Blood; Feces; Probiotics; Strain Isolation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bacteria collection

  One day

• Fecal microbiota composition

  One day

• Immuno-modulatory properties of isolated strains

  One day

Study Arms (1)

Centenarian cohort

Other: Biological samples collection

Interventions

Biological samples collection OTHER

blood drawing + feces collection in a dedicated device

Centenarian cohort

Eligibility Criteria

• Age: 95 Years+
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly (\>95 years old) and centenarians people

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• Previous or current use of a treatment that may disrupt the microbiota (e.g. laxatives, antidiarrheals, antacids...) in the last 3 months
• 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)
• 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

Sponsors & Collaborators

• Bioaster: lead

Study Sites (1)

Gerond'if - Gérontopôle Ile de France

Paris, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood + Stools

Study Officials

• Cyril GUYARD

  Bioaster

  STUDY DIRECTOR

• Olivier HANON

  Gérond'if

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: June 6, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)