What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) include disease-modifying antirheumatic drugs (DMARDs) like methotrexate, biologic agents such as TNF inhibitors, and supplements like omega-3 fatty acids. Methotrexate can cause gastrointestinal symptoms, liver toxicity, and bone marrow suppression. TNF inhibitors may lead to increased risk of infections, injection site reactions, and potential cardiovascular issues. Omega-3 fatty acid supplements are generally well-tolerated but can cause gastrointestinal disturbances and, at high doses, may increase bleeding risk.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Rheumatoid Arthritis (RA) that modulate the immune response. Methotrexate, a disease-modifying antirheumatic drug (DMARD), is often used as a first-line treatment. Biologic agents such as etanercept, adalimumab, and infliximab, which are tumor necrosis factor (TNF) inhibitors, have also been approved and are commonly used. These treatments aim to reduce inflammation and halt disease progression by targeting specific components of the immune system. The trial on Oral Short-Chain Fatty Acid (SCFA) Supplement is exploring a novel approach by potentially modulating the gut microbiome and regulatory immune responses, which could offer a new avenue for RA management.

What other types of research exist?

Promising novel alternatives to oral SCFA supplements for RA patients include: 1) Probiotics, particularly strains like Lactobacillus rhamnosus GG, which have shown benefits in modulating immune responses. 2) Synbiotics, a combination of prebiotics and probiotics, which have demonstrated efficacy in reducing inflammation and improving gut health. 3) Omega-3 fatty acids, which have anti-inflammatory properties and have been studied for their potential benefits in RA. 4) Emerging pharmacological treatments targeting gut microbiota, such as specific bile acid modulators and fibroblast growth factor 21 (FGF21) analogues, which are being investigated for their immunomodulatory effects.

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Butyrate for Rheumatoid Arthritis (EASi-RAIR Trial)

N/A

Recruiting

Led By Rebecca Blank, MD, PhD

Research Sponsored by NYU Langone Health

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 up to month 1 post-treatment initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a supplement with small molecules for RA patients who don't improve with standard treatment. The supplement aims to change gut bacteria and improve immune responses. These molecules are involved in the body's inflammatory response and immunity.

Who is the study for?

This trial is for adults over 18 with Rheumatoid Arthritis who haven't had enough relief from methotrexate. It's not for those with severe liver problems, kidney failure, immune deficiencies like cancer or HIV, pregnant or breastfeeding women, previous SCFA intolerance, recent antibiotic or probiotic use.

What is being tested?

The study tests if an oral supplement of short-chain fatty acids (SCFAs) can help people with Rheumatoid Arthritis by changing their gut bacteria and immune response. Up to 35 participants will take the supplement alongside regular blood, stool, and urine tests over up to two months.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include digestive discomfort due to SCFA intake and possible reactions related to changes in the gut microbiome or immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 1 post-treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 1 post-treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 1 post-treatment initiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Microbiome Alpha Diversity

Secondary study objectives

Change in Fecal SCFA Concentration

Change in Peripheral Regulatory T Cell Concentration

Change in Serum SCFA Concentration

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: RA Patients who are Inadequate Responders to Current RA TreatmentExperimental Treatment1 Intervention

Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2-month time-point.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Butyrate

2021

N/A

~250

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, Janus kinase (JAK) inhibitors, and emerging therapies like short-chain fatty acid (SCFA) supplements. Biologics, such as TNF inhibitors and IL-17 inhibitors, target specific pro-inflammatory cytokines to reduce inflammation and halt disease progression. JAK inhibitors, like tofacitinib, interfere with intracellular signaling pathways that contribute to inflammation. SCFA supplements aim to modulate the gut microbiome and enhance regulatory immune responses, potentially reducing systemic inflammation. These treatments are crucial for RA patients as they target the underlying immune dysregulation, offering relief from symptoms and preventing joint damage.

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