Determination of the Biological Activity of Serum From Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)

Conditions
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Women, Rheumatoid Arthritis

Intervention / Treatment
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* Dietary Supplement: daily supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traitement 1<br>Lactobacillus salivarius | Dietary Supplement: daily supplementation<br>* 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<br>|
| Experimental: Traitement 2<br>Lactobacillus Rhamnosus GG | Dietary Supplement: daily supplementation<br>* 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<br>|
| Experimental: Traitement 3<br>Bifidobacterium lactis | Dietary Supplement: daily supplementation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 0 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 and Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, probiotics