Status:
COMPLETED
Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Unite de Nutrition Humaine UMR 1019- INRAE
Unite MetaGenoPolis INRAE
Conditions:
Healthy Volunteers
Frail Volunteers
Eligibility:
MALE
18-90 years
Phase:
NA
Brief Summary
Human microbial flora transfer studies in rodent models have clearly identified that age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or complications linked to...
Detailed Description
This is a pilot study to validate a process of ex vivo stool transfer from humans to rats. Single-center intervention research with minimal risks and constraints. Exploration of the bacterial composi...
Eligibility Criteria
Inclusion
- Volunteer over the age 18,
- More than 50 kg and having a Body Mass Index (BMI) between 18 and 30 kg / m2 (inclusive),
- Subject aged between 20 and 35 years inclusive ("healthy adult" group, or 65 years (inclusive) and over ("healthy elderly" and "frail elderly" groups),
- Score of the Short Emergency Geriatric Assesment grid (SEGA - A) strictly less than 8 (see appendix 1) ("healthy adult" and "healthy elderly" groups), or greater than or equal to 8 ("frail elderly" group),
- Subject capable of giving informed consent to participate in the research,
- Subject having an affiliation to the French Social Security system.
Exclusion
- Healthy adult group and Healthy elderly group:
- Subject presenting an acute pathology (unstable pathology), a life expectancy of \<3 months or major neuro-cognitive disorders,
- treated with antibiotic therapy 3 months before the start of the protocol,
- in the impossibility of carrying out the planned functionality tests,
- carrier of Pacemaker or implantable defibrillator,
- with renal insufficiency (clearance \<50 ml / min according to the CKD-EPI formula),
- presenting an untreated metabolic syndrome (presenting 3 of the 5 following criteria: waist circumference greater than 94 cm, blood triglyceride level greater than 1.7 mmol / l, blood pressure greater than or equal to 130 mm Hg / 85 mm Hg, cholesterol level (HDL) less than 1.0 mmol / l, fasting blood glucose greater than or equal to 5.6 mmol / l),
- suffering from diabetes (even treated),
- during a slimming diet,
- during treatment with chemotherapy,
- with gastrointestinal pathology,
- with intolerance (milk, lactose, gluten ...) or a diet other than omnivorous (vegetarians, vegans, vegans),
- smoking more than 4 cigarettes / day,
- drinking more than 2 glasses of alcohol per day,
- refusing not to smoke, vape or remove a nicotine patch the morning of the samples,
- having a biological assessment judged by the investigator to be incompatible with the test,
- having a medical and / or surgical history judged by the investigator to be incompatible with the test,
- having drug treatments or nutritional supplements judged by the investigator to be incompatible with the test, (see detail in 8.5)
- having cooperation and understanding that does not allow strict compliance with the conditions set out in the protocol,
- participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation greater than 4500 euros over the 12 months preceding the start of the trial,
- benefiting from a legal protection measure (curatorship, guardianship, safeguard of justice),
- refusing to participate in the study.
- Fragile elderly group:
- Same non-inclusion criteria as above except modification on 2 criteria:
- Renal failure (clearance \<30 ml / min according to the CKD-EPI formula)
- No restriction on the parameters defining the metabolic syndrome unless the subject has treated insulin-dependent diabetes.
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04753580
Start Date
October 4 2021
End Date
September 14 2022
Last Update
October 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU
Clermont-Ferrand, France, 63000