Womennutricell3NCT04696718
Determination of the Biological Activity of Serum From Patients
A study testing daily supplementation in people with Women and Rheumatoid Arthritis, run by Adeline BLOT at 1 site in France.
Trial summary
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts). Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Women, Rheumatoid Arthritis
- What is being tested?
- daily supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 28 Dec 2023
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- 30-75 years
- Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.
- With rheumatoid arthritis (DAS28 threshold specified below)
- Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low
- Person with good venous condition
Who cannot join
- Vaccination in the last two months
- Alcohol abuse with regard to WHO standards
- Smoking (>5 cigarettes/day)
- -> 5 hours of intense sport per week
- Food allergy and others
- Antibiotic treatment in the month preceding inclusion
- Persons under guardianship, curators, deprived of liberties, safeguard of justice
- Refusal to sign the information and consent form
Trial locations and contacts
1 site in 1 country.
emilie gadea, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
emile gadea, PhD, responsable.rechercheclinique@ch-lepuy.fr
About this study
Official title: Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).
The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.
Read the detailed description
The written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study.
Before inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . Their compliance with the inclusion / exclusion criteria will be verified during this review. An interview with personnel involved in the research (a dietician / study Research clinic assistant, etc.) will also be carried out as well as a biological selection assessment.
As part of this study, the subjects will come a total of 7 times to the Emile ROUX hospital in Le Puy en Velay.
The probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. The volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (T = 0) and at the end of the treatment (T = 4 weeks). The study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples.
The sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).
- Conditions
- Women, Rheumatoid Arthritis
- Being tested
- daily supplementation
- Keywords
- rheumatoid arthritis, probiotics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily supplementationDietary supplement
the patients will consume 1 pill of probiotic each day for 28 days per treatments each treatment is separated by a wash out period of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Traitement 1 | Experimental | Lactobacillus salivarius Receives: Dietary Supplement: daily supplementation |
| Traitement 2 | Experimental | Lactobacillus Rhamnosus GG Receives: Dietary Supplement: daily supplementation |
| Traitement 3 | Experimental | Bifidobacterium lactis Receives: Dietary Supplement: daily supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of biological activity of serum between day 0 to day 28
Ex vivo quantification of the formation of osteoclast multi-nucleated cells following culture in the presence of metabolites from the serum of patients between day 0 and day 28
Measured: Day 0 and Day 28
Secondary outcomes (1)
Change of Disease Activity Score (DAS28) day 0 to day 28
The Disease Activity Score (DAS) is a combined index to measure the disease activity in patients with rheumatoid arthritis (RA).
Evaluation of a patient's response to treatment can be made much easier and more objective using the DAS28. (Twenty-eight tender and swollen joint scores include the same joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.) Simply assess the number of swollen and tender joints and measure the ESR. The DAS will provide you with a number between 0 and 10, indicating the activity rate of the rheumatoid arthritis is at that particular moment.
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start20 Dec 2018
- Primary completion22 Dec 2022 (estimated)
- Study completion28 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adeline BLOT
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Emile Roux, Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor-investigator, Adeline BLOT, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- benjamin castagne, MD, Principal investigator, Centre Hospitalier Emile Roux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696718
- Sponsor's protocol ID
- 2018-A00303-52
- Acronym
- nutricell3
- Status last verified
- Aug 2022
- First submitted
- 7 Dec 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)
- ClinicalTrials.gov ID
- NCT04696718
- Acronym / sponsor ID
- nutricell3 / 2018-A00303-52
- Conditions
- Women, Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Adeline BLOTUniversity, hospital or other
- Collaborators
- Centre Hospitalier Emile Roux, Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 28 Dec 2023 (estimated)
- First posted
- 6 Jan 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.
The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).
The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.
Detailed description
The written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study.
Before inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . Their compliance with the inclusion / exclusion criteria will be verified during this review. An interview with personnel involved in the research (a dietician / study Research clinic assistant, etc.) will also be carried out as well as a biological selection assessment.
As part of this study, the subjects will come a total of 7 times to the Emile ROUX hospital in Le Puy en Velay.
The probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. The volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (T = 0) and at the end of the treatment (T = 4 weeks). The study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples.
The sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol
| Arm | Type | Receives |
|---|---|---|
| Traitement 1 | Experimental | Dietary Supplement: daily supplementationLactobacillus salivarius |
| Traitement 2 | Experimental | Dietary Supplement: daily supplementationLactobacillus Rhamnosus GG |
| Traitement 3 | Experimental | Dietary Supplement: daily supplementationBifidobacterium lactis |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- 30-75 years
- Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.
- With rheumatoid arthritis (DAS28 threshold specified below)
- Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low
Key exclusion criteria (8 listed)
- Vaccination in the last two months
- Alcohol abuse with regard to WHO standards
- Smoking (>5 cigarettes/day)
- -> 5 hours of intense sport per week
- Food allergy and others
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 |
|---|---|---|
| daily supplementationthe patients will consume 1 pill of probiotic each day for 28 days per treatments each treatment is separated by a wash out period of 21 days | Dietary supplement | Traitement 1, Traitement 2, Traitement 3 |
Primary outcome
Change of biological activity of serum between day 0 to day 28
Time frame: Day 0 and Day 28
Ex vivo quantification of the formation of osteoclast multi-nucleated cells following culture in the presence of metabolites from the serum of patients between day 0 and day 28
1 secondary outcome
Change of Disease Activity Score (DAS28) day 0 to day 28
Time frame: Day 0 and Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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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.
emilie gadea, PhD contact
benjamin castagne, MD principal investigator
Centre Hospitalier Emile Roux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing daily supplementation in people with Women and Rheumatoid Arthritis, run by Adeline BLOT 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 8 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: status not confirmed, as of the sponsor's last update on 11 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yohann wittrant, PhD (+33682297271, yohann.wittrant@inrae.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of biological activity of serum between day 0 to day 28 (time frame: Day 0 and Day 28). 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 11 Aug 2022.