Clinical trial NCT04696718: Determination of the Biological Activity of Serum From Patients
Official title: Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Women
Rheumatoid Arthritis
Keywords: rheumatoid arthritis
probiotics
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Emile Roux
name: Centre de Recherche en Nutrition Humaine d'Auvergne
First posted: 2021-01-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol
Primary purpose: PREVENTION

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.

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of biological activity of serum between day 0 to day 28
timeFrame: Day 0 and Day 28
Secondary outcomes:
measure: Change of Disease Activity Score (DAS28) day 0 to day 28
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
Study officials:
affiliation: Centre Hospitalier Emile Roux
name: benjamin castagne, MD
role: PRINCIPAL_INVESTIGATOR
References: