Determination of the Biological Activity of Serum From Patients (nutricell3)
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.
研究概览
详细说明
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).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：yohann wittrant, PhD
- 电话号码：+33682297271
- 邮箱：yohann.wittrant@inrae.fr
研究联系人备份
- 姓名：emilie gadea, PhD
- 邮箱：responsable.rechercheclinique@ch-lepuy.fr
学习地点
-
-
-
Le Puy-en-Velay、法国、43000
- 招聘中
- Centre Hospitalier Emile Roux
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接触：
- emile gadea, PhD
- 邮箱：responsable.rechercheclinique@ch-lepuy.fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Traitement 1
Lactobacillus salivarius
|
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
|
|
实验性的：Traitement 2
Lactobacillus Rhamnosus GG
|
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
|
|
实验性的：Traitement 3
Bifidobacterium lactis
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of biological activity of serum between day 0 to day 28
大体时间：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
|
Day 0 and Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of Disease Activity Score (DAS28) day 0 to day 28
大体时间：Day 0 and 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
|
合作者和调查者
赞助
调查人员
- 首席研究员：benjamin castagne, MD、Centre Hospitalier Emile Roux
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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