Determination of the Biological Activity of Serum From Patients
nutricell3
1 other identifier
interventional
20
1 country
1
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 objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2018
CompletedFirst Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2023
CompletedAugust 11, 2022
August 1, 2022
4 years
December 7, 2020
August 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change of Disease Activity Score (DAS28) day 0 to day 28
Day 0 and Day 28
Study Arms (3)
Traitement 1
EXPERIMENTALLactobacillus salivarius
Traitement 2
EXPERIMENTALLactobacillus Rhamnosus GG
Traitement 3
EXPERIMENTALBifidobacterium lactis
Interventions
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
Eligibility Criteria
You may qualify if:
- Women
- 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
You may not qualify if:
- 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
- Persons under guardianship, curators, deprived of liberties, safeguard of justice
- Refusal to sign the information and consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adeline BLOTlead
- Centre Hospitalier Emile Rouxcollaborator
- Centre de Recherche en Nutrition Humaine d'Auvergnecollaborator
Study Sites (1)
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
benjamin castagne, MD
Centre Hospitalier Emile Roux
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blind
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Research Associate
Study Record Dates
First Submitted
December 7, 2020
First Posted
January 6, 2021
Study Start
December 20, 2018
Primary Completion
December 22, 2022
Study Completion
December 28, 2023
Last Updated
August 11, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share