Effects of a short-chain fatty acid supplement on rheumatoid arthritis
A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) Supplement in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)
This study is testing whether a short-chain fatty acid supplement can help people with rheumatoid arthritis who haven't improved enough with their current medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05718583 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the impact of an oral short-chain fatty acid (SCFA) supplement on patients with rheumatoid arthritis (RA) who have not responded adequately to methotrexate. Up to 35 participants will be enrolled, with a target of at least 25 receiving the supplement. The study will assess changes in the gut microbiome and immune responses through clinical data collection, stool, urine, and blood samples at baseline, one month, and optionally at two months. The researchers hypothesize that the SCFA will positively influence the participants' health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of rheumatoid arthritis and inadequate response to methotrexate.
Not a fit: Patients who are pregnant, breastfeeding, or have severe hepatic or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for rheumatoid arthritis patients who do not respond well to traditional treatments.
How similar studies have performed: While the approach of using SCFA in rheumatoid arthritis is novel, similar studies targeting gut microbiome modulation have shown promising results in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis 2. Inadequate response to MTX per treating MD at maximum tolerated dose. 3. Able and willing to provide written informed consent prior to any study specific procedures 4. Age 18 years and above at time of enrollment 5. Subjects not excluded based on race or ethnicity Exclusion Criteria: 1. Participants who are pregnant or are currently breastfeeding 2. History of sensitivity to study compound or any of their excipients 3. Previous intolerance to SCFA or related compounds 4. Current antibiotic treatment (within 3 months of screening) at discretion of PI 5. Current consumption of probiotics (within 3 months of screening) at discretion of PI 6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 7. Renal failure (eGFR \<30 or requiring dialysis) by history 8. History of other autoimmune disease at discretion of PI 9. Current immunodeficiency state (e.g., cancer, HIV, others)
Where this trial is running
New York, New York
- NYU Langone Health Orthopedic Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Blank, MD, PhD — NYU Langone Health
- Study coordinator: Rebecca B. Blank, MD, PhD
- Email: Rebecca.blank@nyulangone.org
- Phone: 212-598-6149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.