What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) include NSAIDs, DMARDs, biologics, and probiotics. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and kidney damage. DMARDs, like methotrexate, may lead to liver toxicity, bone marrow suppression, and lung disease. Biologics, such as TNF inhibitors, can increase the risk of infections and cause injection site reactions. Probiotics, such as Bacillus coagulans and Lactobacillus species, are generally safe with mild gastrointestinal side effects like bloating and gas.

What prior FDA approvals exist?

The FDA has approved several treatments for Rheumatoid Arthritis, including biologic agents and disease-modifying antirheumatic drugs (DMARDs). Biologic agents such as TNF inhibitors (e.g., infliximab, adalimumab) and interleukin inhibitors (e.g., tocilizumab) target specific components of the immune system to reduce inflammation. DMARDs like methotrexate and sulfasalazine work by broadly suppressing the immune response. While these treatments are effective, they differ from the probiotic R-2487, which is being studied for its potential to modulate the gut microbiome and reduce inflammation through a different mechanism.

What other types of research exist?

One promising alternative is Bacillus coagulans GBI-30, 6086, which has been shown to be safe and effective in reducing symptoms of RA in a pilot study. Additionally, other probiotics such as Lactobacillus reuteri and synbiotics (combinations of probiotics and prebiotics) have shown potential in modulating the gut microbiome and reducing inflammation. Larger clinical trials are needed to confirm these findings.

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Probiotic

Probiotic R-2487 for Rheumatoid Arthritis (R-2487-RA01 Trial)

Phase 1

Recruiting

Research Sponsored by Rise Therapeutics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 4

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common side effects from probiotics may include digestive discomfort such as gas or bloating. Since this is a trial to determine safety, monitoring for any adverse reactions is part of the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration

Secondary study objectives

Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)

Change in Simplified Disease Activity Index (SDAI) Score over time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Probiotic

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) include biologics, DMARDs, and probiotics. Biologics, such as TNF inhibitors, target specific components of the immune system to reduce inflammation and halt disease progression. DMARDs, like methotrexate, work by broadly suppressing the immune system to prevent joint damage. Probiotics, such as the R-2487 strain being studied, aim to modulate the gut microbiome, which can influence systemic inflammation and immune responses. This is particularly important for RA patients as an imbalanced gut microbiota has been linked to increased inflammation and disease activity. By restoring a healthy gut microbiome, probiotics may help reduce inflammation and improve clinical outcomes in RA.

Analysis of Gut Microbiota in Rheumatoid Arthritis Patients: Disease-Related Dysbiosis and Modifications Induced by Etanercept.