Determination of the Biological Activity of Serum From Patients (nutricell3)

Adeline BLOT

Status: Enrolling

Conditions: Women; Rheumatoid Arthritis

Treatments: Dietary Supplement: daily supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT04696718

2018-A00303-52

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Traitement 1

Experimental group

Description:

Lactobacillus salivarius

Treatment:

Dietary Supplement: daily supplementation

Traitement 2

Experimental group

Description:

Lactobacillus Rhamnosus GG

Treatment:

Dietary Supplement: daily supplementation

Traitement 3

Experimental group

Description:

Bifidobacterium lactis

Treatment:

Dietary Supplement: daily supplementation