NCT05972590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

July 10, 2023

Last Update Submit

March 18, 2024

Conditions

Elderly Volunteers

Keywords

BiobankHealth AgeingBlood, TruCulturesStoolsStrain isolationProbioticsImmunityVaccination

Outcome Measures

Primary Outcomes (3)

  • Number and ratio of participants with per protocol collection of blood and feces

    Number of volunteers included in the study and number blood/feces pairs collected.

    Baseline

  • Total number of bacteria strains collected

    Isolation and culture of bacteria of interest in anaerobic conditions: constitution of a biobank of Akkermansia muciniphila, Faecalibacterium prausnitzii and Oscillospiraceae) for research purposes.

    Baseline

  • Fecal microbiome richness as assessed by alpha diversity

    Genus and species of bacteria contained in the intestinal microbiota (alpha diversity calculation)

    Baseline

Secondary Outcomes (2)

  • Immunophenotyping of volunteers as assessed by cytokines quantification

    Baseline

  • Immunophenotyping of volunteers as assessed by flow cytometry on immune cells

    Baseline

Study Arms (1)

50-75 years old volunteers cohort

OTHER

Biological samples collection Blood drawing + faeces collection

Other: Biological samples collection (blood + feces)

Interventions

Biological samples collection (blood + feces)OTHER

Blood + stools samples will be collected from each volunteer

50-75 years old volunteers cohort

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged between 50 and 75,
  • BMI between 18.5 and 29 kg/m2,
  • Normal clinical examination,
  • Written consent obtained

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)
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Paris, 75012, France

Location

MeSH Terms

Interventions

Blood Specimen CollectionDefecation

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Cyril GUYARD

    Bioaster

    STUDY DIRECTOR

  • Stéphanie CAVIGIOLI

    BioFortis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

August 2, 2023

Study Start

July 25, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)