Status:
UNKNOWN
Determination of the Biological Activity of Serum From Patients
Lead Sponsor:
Adeline BLOT
Collaborating Sponsors:
Centre Hospitalier Emile Roux
Centre de Recherche en Nutrition Humaine d'Auvergne
Conditions:
Women
Rheumatoid Arthritis
Eligibility:
FEMALE
30-75 years
Phase:
NA
Brief 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). The secondary object...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04696718
Start Date
December 20 2018
End Date
December 28 2023
Last Update
August 11 2022
Active Locations (1)
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1
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France, 43000