Immunological Profile and Microbial Markers in Evaluating the Effectiveness of Probiotic Therapy in RA Patients

NCT05777577 | Unknown

• 1 other identifier: AP14869993
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rheumatoid arthritis (RA) is a common, chronic autoimmune disease that causes joint damage and deformity associated with an increased disability risk and shortened life expectancy (1). New treatment methods have significantly improved disease control, but remission is still difficult to be achieved, so new and improved treatment and diagnostic options are needed for patients stratification and prognosis. To achieve this goal, the proposed study will be aimed at studying RA main factors' relationship. The project's central theme is that microbial dysbiosis is a critical determinant of RA pathogenesis, and the interaction between human factors and the microbiome contributes to the disease risk and it's activity.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• the oral cavity and gut microbiome

  An analysis of the biodiversity of the oral cavity and intestine will be carried out against the background of probiotic therapy: Alpha and Betta diversity according to the main indices: Chao1, Shannon, Simpson etc. The number of taxa associated with the severity of RA will be estimated using LDA. It will be analyzed to what extent probiotic therapy corrects the functional profile of the oral and intestinal microbiomes.

  Change from Baseline the oral cavity and gut microbiome immediately after probiotic therapy

• the oral cavity and gut microbiome

  An analysis of the biodiversity of the oral cavity and intestine will be carried out against the background of probiotic therapy: Alpha and Betta diversity according to the main indices: Chao1, Shannon, Simpson etc. The number of taxa associated with the severity of RA will be estimated using LDA. It will be analyzed to what extent probiotic therapy corrects the functional profile of the oral and intestinal microbiomes.

  Change from Baseline the oral cavity and gut microbiome at 1 month

Secondary Outcomes (2)

• the immunological profile

  Change from Baseline the oral cavity and gut microbiome immediately after probiotic therapy

• the immunological profile

  Change from Baseline the oral cavity and gut microbiome at 1 month

Study Arms (2)

Rheumatoid Arthritis Probiotic (RAP)

EXPERIMENTAL

patients with RA 30-50 yers old, who have 4 or more swollen and painful joints, who did not take probiotic and other drugs that affect the microbiome

Dietary Supplement: probiotic therapy

Rheumatoid Arthritis Probiotic1 (RAP1)

ACTIVE COMPARATOR

closest relatives (brothers and sister, children, parents) living in the same living area and corresponding to the age group, without RA, who did not take probiotic and other drugs that affect the microbiome

Dietary Supplement: probiotic therapy

Interventions

probiotic therapy DIETARY_SUPPLEMENT

probiotic including bifidobacterium

Rheumatoid Arthritis Probiotic (RAP); Rheumatoid Arthritis Probiotic1 (RAP1)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ● age 30-50 years old
• signed informed consent
• Have a clinical diagnosis of RA (according to American College of Rheumatologyhttps (ACR) criteria)
• Have been on stable RA treatment and are expected to remain on stable RA treatment during the study (ie, current medications and/or other therapies such as physical therapy are allowed, excluding immunotherapy).
• Have at least 4 swollen and painful joints on a 64/66 scale.
• absence of acute infectious diseases at the time of recruitment
• absence of exacerbations of chronic diseases at the time of recruitment
• no history of regular use of probiotic-containing products
• no history of the use of any drugs that affect the composition of the microbiome during the last three months: antibiotics, probiotic, prebiotics, metabiotics, postbiotic

You may not qualify if:

• ● History of any systemic disease such as diabetes, autoimmune disease, cancer (excluding basal and squamous cell skin cancer, which have been cured) !!! taking into account the main study group
• History of gastrointestinal or liver disease known to be associated with changes in intestinal flora
• Use of any of the drugs listed below within the past 6 months:
• systemic antibiotics, antifungal, antiviral or antiparasitic (intravenously, intramuscularly or orally);
• oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
• cytokines;
• large doses of commercial probiotic (greater than or equal to 10\^8 cfu per day) - includes tablets, capsules, dragees, chewing gums or powders, where probiotic bacteria is the main component
• Use of topical antibiotics or topical steroids on the face, scalp or neck, or on the arms, forearms, hands within the previous 7 days.
• Chronic diseases requiring current medical treatment
• Unstable dietary history, major changes in diet during the previous month.
• Positive test for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Gastrointestinal surgery, excluding cholecystectomy and appendectomy in the last five years. Any major bowel resection at any time.
• Regular urinary incontinence
• Feeding or pregnancy.
• Have had warts or human papillomavirus (HPV) with a confirmed diagnosis within the previous 2 years.

Sponsors & Collaborators

• Nazarbayev University: lead
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Almagul Kushugulova, Professor

CONTACT

+7172 706498; akushugulova@nu.edu.kz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 21, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share