Determination of the Biological Activity of Serum From Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Women
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocolMasking: Single (Participant)Masking Description: single blindPrimary Purpose: Prevention
Participation Requirements
- Age
- Between 30 years and 75 years
- Gender
- Only males
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 an interview on personal and family history and drug treatments taken as well as a standard medical ex...
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).
Tracking Information
- NCT #
- NCT04696718
- Collaborators
- Centre Hospitalier Emile Roux
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Investigators
- Principal Investigator: benjamin castagne, MD Centre Hospitalier Emile Roux