Status:
COMPLETED
Characterization of Fecal Microbiota in a Population Aged 50 to 75 Years Targeted by Seasonal Vaccination
Lead Sponsor:
Bioaster
Collaborating Sponsors:
BioFortis
Conditions:
Elderly Volunteers
Eligibility:
All Genders
50-75 years
Phase:
NA
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...
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) tec...
Eligibility Criteria
Inclusion
- Subjects aged between 50 and 75,
- BMI between 18.5 and 29 kg/m2,
- Normal clinical examination,
- Written consent obtained
Exclusion
- 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
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05972590
Start Date
July 25 2023
End Date
December 15 2023
Last Update
March 19 2024
Active Locations (1)
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1
Biofortis
Paris, France, 75012