Healthy VolunteersFRAGIBIOTENCT04753580
Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging
A study testing Stool collection in people with Healthy Volunteers and Frail Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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 aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Frail Volunteers
- What is being tested?
- Stool collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2021to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance.
This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.
Read the 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 composition of the intestinal microbiota in healthy adult volunteers, healthy elderly and frail elderly. The evaluation of the bacterial population of the stool will be done by analysis of the 16S rRNA gene.
The secondary objectives will evaluate the muscular functional abilities the body composition measurement, at Day 0 (visit 2) and the inflammatory status at Day -7 (visit 1).
Seconds parameters are the following :
seated, standing, walking, and direction changes, a balance test, a walking speed test and a chair lift test, the maximum voluntary force of manual gripping, the maximum muscle strength of the quadriceps and the level of autonomy
This protocol includes 3 visits :
- Visit 1 : Day -7 (allowed until Day-14) = inclusion
- Visit 2 : Day 0 = tests and questionnaires
- Visit 3 : Day +7 (allowed from Day+1) = stool collect
- Conditions
- Healthy Volunteers, Frail Volunteers
- Being tested
- Stool collection
- Keywords
- Genetic, Elderly, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionGenetic
The volunteer will receive the stool collection kit as well as the procedure to follow for this collection.
Treatment of stool after collection:
The stool will be treated according to the following two procedures:
- part of the stool will be sequenced and will be stored as quickly as possible (4 hours maximum) at -80 ° C, 3 separate aliquots of 1 g; ii) the other part will be intended for implantation in rats and must be homogenized in a final concentration of 20% glycerol (2 hours maximum) and then stored at -80 ° C, 3 aliquots of 1 g.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | healthy adult 20-35 years old Receives: Genetic: Stool collection |
| group 2 | Experimental | healthy elderly 65+ years old Receives: Genetic: Stool collection |
| group 3 | Experimental | Frail elderly 65+ years old Receives: Genetic: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the bacterial population of the stool by analysis of the 16S rRNA gene
Random metagenomic sequencing. The DNA sequences obtained will be aligned with catalogs of genes and microbial species representative of the gut microbiota to obtain a detailed microbial and functional profile (catalog of 10.4 million genes and ~ 2000 intestinal microbial species)
Measured: Day +7
Secondary outcomes (28)
Measurement of muscular functional aptitudes with the Get up and Go muscular test scale
Test that assesses seated, standing, walking and changes of direction transfers. This is a simple validated field test modified secondarily by adding the measured time. The subject is seated on a chair with armrests, placed in front of a wall 3 meters away. The subject should stand up, remain standing, walk to the wall, turn around without touching the wall, return to the seat, walk around it and sit down again. The rating is carried out with a scale rated from 1 to 5: 1 - no instability ; 2 - very slightly abnormal (slow execution) ; 3 - moderately abnormal (hesitation, compensatory movements) ; 4 - abnormal (the patient trips) ; 5 - very abnormal (permanent risk of falling).
Measured: Day 0
Measurement of muscular functional aptitudes with the Short Physical Performance Battery (SPPB) score
This test includes a balance test, a walking speed test and a chair lift test. It makes it possible to assess the physical performance of an individual. Adding up the scores for all tests provides an overall performance score. A score of less than 8 is an indicator of the risk of sarcopenia (or age-related muscular dystrophy)
Measured: Day 0
Evaluation of the the maximum voluntary force of manual gripping.
Measurement (in Newton) carried out on the dominant limb in a seated position, elbow resting on a table, with a Jamard dynamometer. The subject must make a gripping movement as hard as possible. Three reproducible measurements (+/- 10%) will be taken at 1 minute intervals and the highest value will be retained.
Measured: Day 0
Evaluation of the voluntary level of autonomy with Functional Independence Measure (FIM) questionnaire
This test includes 18 items that assess a person's level of autonomy in their daily activities. Motor skills are measured by 13 tasks which are grouped under 4 categories of activities:
Cognitive abilities are measured by 5 tasks which are grouped under 2 categories of activities:
Measured: Day 0
Measurement of the distance travelled in 6 minutes with the 6-minute walk test
6-minute walk test performed according to ATS recommendations. Measurement of the distance travelled in 6 minutes in a lane of 30 meters by the subject with collection of basic parameters (heart rate).
Measured: Day 0
Fat mass ratio determination
The percentage of fat mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Measured: Day 0
Lean mass ratio determination
The percentage of lean mass (%) (body composition) will be determined on each participant using a multi-frequency bioelectrical Impedance Analyzer.
Measured: Day 0
Water mass ratio determination
The percentage of water (%) (body composition) will be determined using a multi-frequency bioelectrical Impedance Analyzer.
Measured: Day 0
Evaluation of the participant nutritional state with Mini Nutritional Assessment (MNA)
The Mini Nutritional Assessment is structured in 18 questions grouped in four rubrics (anthropometry, general status, dietary habits, and self-perceived health and nutrition states). It allows grading the nutritional status according to defined thresholds: scores above 24 = good status; scores 23.5-17 = risk of malnutrition; scores below 17 = malnutrition.
Measured: Day -7
Evaluation of the participant cognitive state with Mini Mental State Examination (MMSE)
The Mini Mental State Examination is structured in 30 questions grouped in six rubrics (orientation, registration, attention and calculation, memory, language, and copying). It allows the screening of cognitive impairments.
Measured: Day -7
Plasma glucose dosage
Determination of glucose plasma concentration (mmol/L) (a metabolic parameter).
Measured: Day -7
Plasma creatinine dosage
Determination of creatinine plasma concentration (µmol/L) (a metabolic parameter).
Measured: Day -7
Creatinine clearance
Determination of the creatinine clearance (ml/min) (a metabolic parameter).
Measured: Day -7
Plasma albumin dosage
Description: Determination of albumin plasma concentration (a metabolic parameter).
Measured: Day -7
Plasma total cholesterol dosage
Determination of total cholesterol plasma concentration (mmol/L) (a metabolic parameter).
Measured: Day -7
Plasma High Density Lipoprotein cholesterol (HDL-chol) dosage
Description: Determination of HDL-chol plasma concentration (mmol/L) (a metabolic parameter).
Measured: Day -7
Plasma triglycerides dosage
Determination of triglycerides concentration (mmol/L) (a metabolic parameter).
Measured: Day -7
Plasma liver enzymes (AST/ALT/GGT) dosage
Determination of liver enzymes concentration (U/L) (a metabolic parameter).
Measured: Day -7
Plasma phosphatase alkaline dosage
Determination phosphatase alkaline concentration (U/100mL) (a metabolic parameter).
Measured: Day -7
Plasma C-reactive protein dosage
Determination C-reactive protein concentration (a metabolic parameter).
Measured: Day -7
Complete blood count (CBC)
Determination of the number of erythrocytes (millions/mm3), leukocytes (mm3/1000), platelets (mm3/1000), the hematocrit rate (%), the hemoglobin rate (g/100ml), the mean corpuscular hemoglobin (pg), mean corpuscular volume (µ3), mean corpuscular hemoglobin concentration (%)
Measured: Day -7
Dosage of TNF-alpha allowing assessment of inflammatory status
Determination of TNF-alpha plasma concentration (pg/ml)
Measured: Day -7
Dosage of IL1 allowing assessment of inflammatory status
Determination of IL-1 plasma concentration (pg/ml)
Measured: Day -7
Dosage of IL6 allowing assessment of inflammatory status
Determination of IL-6 plasma concentration (pg/ml)
Measured: Day -7
Dosage of MCP1 allowing assessment of inflammatory status
Determination of MCP1 plasma concentration (pg/ml)
Measured: Day -7
Dosage of IL10 allowing assessment of inflammatory status
Determination of IL10 plasma concentration (pg/ml)
Measured: Day -7
Dosage of LPS-binding protein allowing assessment of inflammatory status
Determination of LPS-binding protein plasma concentration (ng/ml)
Measured: Day -7
Dosage of sDC14 allowing assessment of inflammatory status
Determination of sDC14 plasma concentration (ng/ml)
Measured: Day -7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start4 Oct 2021
- Primary completion14 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Unite de Nutrition Humaine UMR 1019- INRAE, Unite MetaGenoPolis INRAE, France MICALIS Equipe ProbiHote UMR INRAE
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753580
- Sponsor's protocol ID
- RBHP 2020 PICKERING 3
- Other IDs
- 2020-A02978-31
- Acronym
- FRAGIBIOTE
- Status last verified
- Jul 2022
- First submitted
- 11 Feb 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging
- ClinicalTrials.gov ID
- NCT04753580
- Acronym / sponsor ID
- FRAGIBIOTE / RBHP 2020 PICKERING 3
- Conditions
- Healthy Volunteers, Frail Volunteers
- Keywords
- Genetic, Elderly, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Unite de Nutrition Humaine UMR 1019- INRAE, Unite MetaGenoPolis INRAE, France MICALIS Equipe ProbiHote UMR INRAE
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance.
This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.
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 composition of the intestinal microbiota in healthy adult volunteers, healthy elderly and frail elderly. The evaluation of the bacterial population of the stool will be done by analysis of the 16S rRNA gene.
The secondary objectives will evaluate the muscular functional abilities the body composition measurement, at Day 0 (visit 2) and the inflammatory status at Day -7 (visit 1).
Seconds parameters are the following :
seated, standing, walking, and direction changes, a balance test, a walking speed test and a chair lift test, the maximum voluntary force of manual gripping, the maximum muscle strength of the quadriceps and the level of autonomy
This protocol includes 3 visits :
- Visit 1 : Day -7 (allowed until Day-14) = inclusion
- Visit 2 : Day 0 = tests and questionnaires
- Visit 3 : Day +7 (allowed from Day+1) = stool collect
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Genetic: Stool collectionhealthy adult 20-35 years old |
| group 2 | Experimental | Genetic: Stool collectionhealthy elderly 65+ years old |
| group 3 | Experimental | Genetic: Stool collectionFrail elderly 65+ years old |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (26 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool collectionThe volunteer will receive the stool collection kit as well as the procedure to follow for this collection. Treatment of stool after collection: The stool will be treated according to the following two procedures: i) part of the stool will be sequenced and will be stored as quickly as possible (4 hours maximum) at -80 ° C, 3 separate aliquots of 1 g; ii) the other part will be intended for implantation in rats and must be homogenized in a final concentration of 20% glycerol (2 hours maximum) and then stored at -80 ° C, 3 aliquots of 1 g. | Genetic | group 1, group 2, group 3 |
Primary outcome
Evaluation of the bacterial population of the stool by analysis of the 16S rRNA gene
Time frame: Day +7
Random metagenomic sequencing. The DNA sequences obtained will be aligned with catalogs of genes and microbial species representative of the gut microbiota to obtain a detailed microbial and functional profile (catalog of 10.4 million genes and ~ 2000 intestinal microbial species)
28 secondary outcomes
Measurement of muscular functional aptitudes with the Get up and Go muscular test scale
Time frame: Day 0
Measurement of muscular functional aptitudes with the Short Physical Performance Battery (SPPB) score
Time frame: Day 0
Evaluation of the the maximum voluntary force of manual gripping.
Time frame: Day 0
Evaluation of the voluntary level of autonomy with Functional Independence Measure (FIM) questionnaire
Time frame: Day 0
Measurement of the distance travelled in 6 minutes with the 6-minute walk test
Time frame: Day 0
Fat mass ratio determination
Time frame: Day 0
Lean mass ratio determination
Time frame: Day 0
Water mass ratio determination
Time frame: Day 0
Evaluation of the participant nutritional state with Mini Nutritional Assessment (MNA)
Time frame: Day -7
Evaluation of the participant cognitive state with Mini Mental State Examination (MMSE)
Time frame: Day -7
Plasma glucose dosage
Time frame: Day -7
Plasma creatinine dosage
Time frame: Day -7
Creatinine clearance
Time frame: Day -7
Plasma albumin dosage
Time frame: Day -7
Plasma total cholesterol dosage
Time frame: Day -7
Plasma High Density Lipoprotein cholesterol (HDL-chol) dosage
Time frame: Day -7
Plasma triglycerides dosage
Time frame: Day -7
Plasma liver enzymes (AST/ALT/GGT) dosage
Time frame: Day -7
Plasma phosphatase alkaline dosage
Time frame: Day -7
Plasma C-reactive protein dosage
Time frame: Day -7
Complete blood count (CBC)
Time frame: Day -7
Dosage of TNF-alpha allowing assessment of inflammatory status
Time frame: Day -7
Dosage of IL1 allowing assessment of inflammatory status
Time frame: Day -7
Dosage of IL6 allowing assessment of inflammatory status
Time frame: Day -7
Dosage of MCP1 allowing assessment of inflammatory status
Time frame: Day -7
Dosage of IL10 allowing assessment of inflammatory status
Time frame: Day -7
Dosage of LPS-binding protein allowing assessment of inflammatory status
Time frame: Day -7
Dosage of sDC14 allowing assessment of inflammatory status
Time frame: Day -7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool collection in people with Healthy Volunteers and Frail Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the bacterial population of the stool by analysis of the 16S rRNA gene (time frame: Day +7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.