Determination of the Biological Activity of Serum From Patients
NCT ID: NCT04696718
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-12-20
2023-12-28
Brief Summary
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The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Traitement 1
Lactobacillus salivarius
daily supplementation
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
Traitement 2
Lactobacillus Rhamnosus GG
daily supplementation
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
Traitement 3
Bifidobacterium lactis
daily supplementation
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
Interventions
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daily supplementation
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Years
75 Years
FEMALE
No
Sponsors
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Centre Hospitalier Emile Roux
OTHER
Centre de Recherche en Nutrition Humaine d'Auvergne
OTHER_GOV
Adeline BLOT
OTHER
Responsible Party
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Adeline BLOT
Clinical Research Associate
Principal Investigators
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benjamin castagne, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Emile Roux
Locations
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Centre Hospitalier Emile Roux
Le Puy-en-Velay, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A00303-52
Identifier Type: -
Identifier Source: org_study_id
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