M05
Conditions
Interventions
Group 1: Specific synbiotic with > 1 billion colony forming units (CFU) Bacillus megaterium DSM 32963 and 596 mg Omega-3 lysine complex) on top of standard-of-care treatment
oral, 2 capsules/day
duration of nutritional intervention: 6 months
Group 2: Placebo on top of standard-of-care treatment (control group)
2 capsules/day
duration of intervention: 6 months
Sponsors
Weber & Weber GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Patients freshly diagnosed with RA (= DMRAD treatment naive) based on the 2010 ARC/EULAR classification criteria (classification criteria score =6) with start of MTX therapy between 10-20 mg/week - Patients have at least 3 swollen and tender joints - Patients have at least a CRP value of 1.0 mg/dL - Patients are positive for rheumatoid factor (RF) [anti-IgG, M, A above upper limit of normal] and/or have anti-citrullinated protein antibodies (ACPA such as anti-CCP or anti-MCV) 3 times above the upper limit of normal. - Written consent to participate in the study - Able and willing to follow the study procedures
Exclusion criteria
Exclusion criteria: 1. Patients with RA symptoms present for longer than 12 months. 2. Regular intake of systemic glucocorticoids (max. 0.5 mg/kg body weight prednisolone daily) for more than 6 months prior to study inclusion. 3. Prior therapy with other conventional, biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). 4. Known hypersensitivity to the ingredients of the investigational nutritional supplement. 5. Regular intake of supplements containing probiotic bacteria in the last 1 month or supplements containing omega 3 fatty acids (e.g. fish oil; containing more than 250 mg EPA + DHA per day) in the last 1 month or during the study. 6. Patients having a relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. ongoing severe heart failure, heavy depression, acute cancers within last 5 years except basal cell carcinoma of the skin, cervix carcinoma in situ, or patients with other active conditions that may require systemic glucocorticoid therapy.) 7. Any history of chronic infection such as HIV, TBC, Hepatitis B) or any other autoimmune or rheumatic disease (except Hashimoto thyroiditis, completely cured TBC infection). 8. Patients that are pregnant or have a wish for pregnancy and are therefore not willing to adhere to contraception (= women of childbearing age that have a positive pregnancy test). 9. Patients that abuse alcohol or drugs. 10. Patients that are not able to communicate verbally, and not able to understand study instructions. 11. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product or nutritional product within 30 days prior to written informed consent for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients that need an escalation (change of RA therapy) of their first line therapy with methotrexate (MTX) therapy after 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Omega-3 index (day 0, 24 weeks) - Proportion of participants achieving “no response”, “moderate response” or “good response” improvement in the EULAR validated disease activity composite score DAS28-4[CRP] (after 24 weeks) - Proportion of patients in remission (DAS28-4[CRP] < 2.6) and in low-disease activity (DAS28-4[CRP] < 3.2) (after 24 weeks) - Proportion of patients meeting the Boolean-defined low disease activity (LDA) (PGA max 2cm of 10 cm; max 1 T or S joint; CRP max. 1mg/dL] (after 24 weeks) - Proportion / frequency of patients in remission according to Boolean 2.0 definition (after 24 weeks) - Markers of inflammation: CRP, ESR (Erythrocyte sedimentation rate) (day 0, week 6, week 12, week 18, week 24) - DAS28-4[CRP] (day 0, week 6, week 12, week 18, week 24) - DAS28-4[ESR] (day 0, week 6, week 12, week 18, week 24) - Simple Disease Activity Index for Rheumatoid Arthritis (SDAI) (day 0, week 6, week 12, week 18, week 24) - Clinical Disease Activity Index for Rheumatoid Arthritis (CDAI) (day 0, week 6, week 12, week 18, week 24) - RAID questionnaire (day 0, week 6, week 12, week 18, week 24) - RAPID-3 score (day 0, week 6, week 12, week 18, week 24) - Pain scale (PN) (part of RAPID 3) (day 0, week 6, week 12, week 18, week 24) - Duration of morning stiffness (day 0, week 6, week 12, week 18, week 24) - Patient global assessment via NRS Scale (PGA) (day 0, week 6, week 12, week 18, week 24) - Evaluators (doctor) global assessment via NRS Scale (EGA) (day 0, week 6, week 12, week 18, week 24) - Microbiome composition (day 0, week 24) | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed