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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: yohann wittrant, PhD
- Número de telefone: +33682297271
- E-mail: yohann.wittrant@inrae.fr
Estude backup de contato
- Nome: emilie gadea, PhD
- E-mail: responsable.rechercheclinique@ch-lepuy.fr
Locais de estudo
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-
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Le Puy-en-Velay, França, 43000
- Recrutamento
- Centre Hospitalier Emile Roux
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Contato:
- emile gadea, PhD
- E-mail: responsable.rechercheclinique@ch-lepuy.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Traitement 1
Lactobacillus salivarius
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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
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Experimental: Traitement 2
Lactobacillus Rhamnosus GG
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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
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Experimental: Traitement 3
Bifidobacterium lactis
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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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of biological activity of serum between day 0 to day 28
Prazo: Day 0 and Day 28
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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
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Day 0 and Day 28
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change of Disease Activity Score (DAS28) day 0 to day 28
Prazo: Day 0 and Day 28
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: benjamin castagne, MD, Centre Hospitalier Emile Roux
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2018-A00303-52
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