Probiotic R-2487 for Rheumatoid Arthritis
(R-2487-RA01 Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Rise Therapeutics LLC
Must be taking: Hydroxychloroquine, Methotrexate, Leflunomide
Must not be taking: Rituximab, Abatacept, Infliximab, others
Disqualifiers: Autoimmune diseases, Active infections, HIV, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a probiotic supplement taken by mouth to see if it is safe and well-tolerated in people with Rheumatoid Arthritis. The goal is to find out if improving gut health can help reduce inflammation and manage symptoms of the disease. Probiotics, including various Lactobacillus species, have been studied for their potential to alleviate symptoms of rheumatoid arthritis by normalizing gut microbiota and reducing inflammation.
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications like hydroxychloroquine, methotrexate, and leflunomide, but not sulfasalazine. If you have been on targeted synthetic DMARDs or certain other medications, you may need to stop them for a specific period before joining the trial. It's best to discuss your current medications with the trial team to see if any changes are needed.
What data supports the effectiveness of the treatment R-2487 for rheumatoid arthritis?
Research shows that probiotics, like R-2487, can help improve symptoms of rheumatoid arthritis by reducing inflammation and disease activity. Some studies found that probiotics can lower certain inflammation markers and improve joint health, although more research is needed to confirm these effects.
12345Is Probiotic R-2487 safe for humans?
Probiotics, including strains like Lactobacillus casei, have been studied in people with rheumatoid arthritis and generally show no significant adverse effects, suggesting they are safe for human use. However, more research is needed to confirm the safety of specific strains like B. longum RAPO in humans.
46789How is the treatment R-2487 different from other treatments for rheumatoid arthritis?
R-2487 is a probiotic treatment that aims to improve rheumatoid arthritis symptoms by normalizing gut microbiota, which is different from traditional treatments that typically focus on reducing inflammation directly. This approach is unique because it targets the gut bacteria imbalance that may contribute to the disease.
145610Eligibility Criteria
Adults aged 18-75 with active Rheumatoid Arthritis, not pregnant or nursing, who agree to use birth control and avoid vaccinations during the study. Participants must have a certain level of disease activity and can be on some RA medications but must have stopped others for specified times before joining.Inclusion Criteria
I stopped taking certain RA medications like tofacitinib a month ago.
I am between 18 and 75 years old.
I will not get any vaccines during the study, including flu or COVID shots.
+6 more
Exclusion Criteria
I have had active tuberculosis in the past.
Subjects with recent acute infection defined as: Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics, Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy, Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.), Subjects with any history of infection of a joint prosthesis or artificial joint, Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis), Subjects with history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster will be excluded, Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening, Subjects with history of primary immunodeficiency, Subjects with history of Human Immunodeficiency Virus (HIV) infection or who tested positive for HIV, Evidence of infection with hepatitis B virus (HBV), hepatitis C virus (C), human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening, Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non- metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations, Current clinical findings of a history of a demyelinating disorder, New York Heart Association (NYHA) Class III or IV heart failure, Subjects who have undergone a major surgical procedure within the 60 days prior to enrollment, Subjects for whom 5 or more joints cannot be assessed for tenderness or swelling (i.e. due to surgery, fusion, amputation, etc.), Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following: Hemoglobin level < 9.0 g/dL, Absolute white blood cell (WBC) count of <3.0×109/L (<3000/mm3), or absolute neutrophil count of <1.2×109/L (<1200/mm3), or absolute lymphocyte count of <0.8×109/L (<800/mm3), Thrombocytopenia, defined by platelet count <100×109/L (<100,000/mm3), Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, based on the age-appropriate calculation, Proteinuria ≥3+, Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN), Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3), Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio
Pregnancy (females, unless surgically sterile or at least two years post- menopausal must have a negative serum pregnancy test within 14 days prior to receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug)
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive an oral dosage of probiotic (R-2487) and are assessed for safety and tolerability
4 weeks
Weekly visits for assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing R-2487, an oral probiotic, for safety and effectiveness in treating Rheumatoid Arthritis. Patients' symptoms will be monitored through blood tests and assessments of inflammation in the body.
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Probiotic
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AP Medical ResearchMiami, FL
St.Jude Clinical ResearchDoral, FL
Dartmouth Hitchcock Medical Center (DHMC)Lebanon, NH
Altoona Center for ResearchDuncansville, PA
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Who Is Running the Clinical Trial?
Rise Therapeutics LLCLead Sponsor
References
Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. [2022]Rheumatoid arthritis (RA) is an inflammatory autoimmune disease in which the gut microbiota is altered. Probiotics are microorganisms that can normalize gut microbiota; thus, they may help to alleviate RA symptoms. The objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with RA.
A randomized, double-blinded, placebo-controlled pilot study of probiotics in active rheumatoid arthritis. [2022]To examine the effect of probiotics as adjunctive therapy for the treatment of rheumatoid arthritis (RA). A sample size of 30 subjects was calculated to determine a moderate effect.
Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial. [2022]Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications.
The efficacy of probiotic supplementation in rheumatoid arthritis: a meta-analysis of randomized, controlled trials. [2021]Probiotics are considered as -immunomodulatory agents; their efficacy as an adjunct therapy option for rheumatoid arthritis (RA), however, remains controversial. The main aim of the present meta-analysis, therefore, was to compare available data from the published randomized, controlled trials (RCTs) recruiting adults with RA which compared probiotics with placebo. The English literature search was performed using Ovid version of Medline, EmBase, Web of Science, and the Central Cochrane library through October 2016 and supplemented by hand searching reference lists. Among 240 citations identified, 4 RCTs (153 participants; 89% female) were included. All data were pooled using a standardized mean difference (SMD) with a 95% CI. Compared to the placebo, probiotics did not change the inflammatory parameters (erythrocyte sedimentation rate, tumor necrosis factor [TNF]-α, interleukin [IL]-1β, IL-6, IL-10, and IL-12) and oxidative stress indices (total antioxidant capacity and malondialdehyde) significantly. The borderline significant reduction as a result of probiotic administration was only determined in C-reactive protein [SDM - 0.32 (95% CI - 0.65 to 0.00)]. Among disease activity indices (disease activity score [DAS], tender joint count, and swollen joint count), DAS showed a significant improvement following probiotic treatment with a SMD (95% CI) of - 0.58 (- 0.97 to - 0.19). The number of trials was too small to determine if a strain-, dose-, or duration-response effect was present. Probiotics seem to be less effective in RA; however, to reach a firm conclusion, we need further evidence.
Can Probiotic Supplements Improve Outcomes in Rheumatoid Arthritis? [2022]The purpose of this review is to frame the discussion of the potential use of probiotics for the management of rheumatoid arthritis (RA) in the historical and scientific context linking the human microbiota to the etiology, pathogenesis, and treatment of RA. Given this context, the review then details the clinical trials that have been carried out so far that have tried to address the question.
Effects of Probiotic Supplementation on Oxidative Stress Indices in Women with Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial. [2022]Rheumatoid arthritis (RA) is an autoimmune inflammatory disease that causes great pain and disability and increasing oxidative stress in patients. The objective of the present study was to evaluate the effects of probiotics-live microorganisms with many health benefits, including antioxidant properties-on oxidative stress indices of patients with RA. This study is a secondary analysis from a previously published study Methods: In a randomized double-blind placebo-controlled clinical trial, 46 patients with RA were assigned to one of two groups; patients in the probiotic group received a daily capsule containing 10(8) colony forming units (CFUs) of Lactobacillus casei 01 (L. casei 01), while those in the placebo group took identical capsules containing maltodextrin, for 8 weeks. In the baseline and at the end of the study, anxiety, physical activity levels, and dietary intakes were assessed. Anthropometric parameters, serum malondialdehyde (MDA), total antioxidant capacity (TAC), erythrocyte superoxide dismutase (SOD), glutathione peroxidase (GPx), and catalase (CAT) activities were measured.
Effectiveness of probiotics in the management of inflammatory arthritis: a systematic review protocol. [2023]The questions of this systematic review are: i) What is the effectiveness of probiotics as a therapeutic intervention for individuals living with inflammatory arthritis? ii) What are the reported adverse effects of probiotics when used as a therapeutic intervention for individuals living with inflammatory arthritis?
Therapeutic Potential of a Novel Bifidobacterium Identified Through Microbiome Profiling of RA Patients With Different RF Levels. [2021]The potential therapeutic effects of probiotic bacteria in rheumatoid arthritis (RA) remain controversial. Thus, this study aimed to discover potential therapeutic bacteria based on the relationship between the gut microbiome and rheumatoid factor (RF) in RA. Bacterial genomic DNA was extracted from the fecal samples of 93 RA patients and 16 healthy subjects. Microbiota profiling was conducted through 16S rRNA sequencing and bioinformatics analyses. The effects of Bifidobacterium strains on human peripheral blood mononuclear cells and collagen-induced arthritis (CIA) mice were assessed. Significant differences in gut microbiota composition were observed in patients with different RF levels. The relative abundance of Bifidobacterium and Collinsella was lower in RF-high than in RF-low and RF-negative RA patients, while the relative abundance of Clostridium of Ruminococcaceae family was higher in RF-high than in RF-low and RF-negative patients. Among 10 differentially abundant Bifidobacterium, B. longum RAPO exhibited the strongest ability to inhibit IL-17 secretion. Oral administration of B. longum RAPO in CIA mice, obese CIA, and humanized avatar model significantly reduced RA incidence, arthritis score, inflammation, bone damage, cartilage damage, Th17 cells, and inflammatory cytokine secretion. Additionally, B. longum RAPO significantly inhibited Th17 cells and Th17-related genes-IL-17A, IRF4, RORC, IL-21, and IL-23R-in the PBMCs of rheumatoid arthritis patients. Our findings suggest that B. longum RAPO may alleviate RA by inhibiting the production of IL-17 and other proinflammatory mediators. The safety and efficacy of B. longum RAPO in patients with RA and other autoimmune disorders merit further investigation.
Effects of probiotic supplementation on lipid profile of women with rheumatoid arthritis: A randomized placebo-controlled clinical trial. [2022]Background: Probiotics are live beneficial microorganisms which may exert hypolipidemic effects through many mechanisms. Lipid profile disturbances are frequently reported in rheumatoid arthritis (RA) patients. The objective of this study was to evaluate the effects of Lactobacillus casei on serum lipids of RA women. Methods: In the present parallel randomized double-blind placebo-controlled clinical trial, 60 RA patients were recruited and divided into 2 groups. They received either a daily capsule containing 108 CFU of L. casei 01, or identical capsules containing maltodextrin, for 8 weeks. Anthropometric parameters, dietary intake and physical activity were assessed at 2 ends of the study. Serum levels of total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C) and triglyceride (TG) were measured. Independent-samples t test and analysis of covariance (ANCOVA) test, and paired t test were used to test between- and within-group differences, respectively. Results: There were no significant between- or within-group differences for demographic and anthropometric parameters, physical activity and dietary intakes, throughout the study. No statistically significant within-group changes were observed for serum lipids in either group; between-group differences were also insignificant by the end of study period (TC: -0.18 [-0.65, 0.29], P = 0.801, HDL-C: -1.66 [-19.28, 15.59], P = 0.663, LDL-C: -2.73 [-19.17, 13.73], P = 0.666, TG: 0.12 [-19.76, 20.00], P = 0.900). Conclusion: Lactobacillus casei 01 could not improve serum lipids in RA patients. Further studies using probiotic foods and different probiotic strains are suggested.
[THE USE OF PROBIOTICS IN PATIENTS WITH RHEUMATOID ARTHRITIS]. [2020]The results of biological research of colon microbiota of patients with rheumatoid arthritis (RA) is in article presented. The signs of III degree dysbiosis, by reducing the concentration of Bacteroides spp., Bifidobacterium spp., Lactobacillus spp. populations, typical strain E. coli. But over growth of populations Klebsiella spp., Proteus spp., Staphylococcus spp., atypical forms of E. coli, Candida spp. The scheme for the correction of the colon microflora of patients with (RA) by was proposed bifiform. Increasing of populations concentration of Bifidobacterium spp., Bacteroides spp., Lactobacillus spp., typical E. coli, Enterococcus spp. and selective decontamination of Enterococcus (Hly+), Klebsiella spp., Proteus spp., Staphylococcus spp., lactosonegative and E.coli (Hly+) confirmed after using of this eubiotics.