Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Completed · Not applicable

Conditions studied: Rheumatoid Arthritis

In brief

This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize that oral SCFA will change the participants' gut microbiome and regulatory immune responses. 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. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.

Key facts

Study ID

NCT05718583

Run by

NYU Langone Health

People needed

20

Starts

2023-02-01

Expected to finish

2025-02-20

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
• Inadequate response to MTX per treating MD at maximum tolerated dose.
• Able and willing to provide written informed consent prior to any study specific procedures
• Age 18 years and above at time of enrollment
• Subjects not excluded based on race or ethnicity

You may not qualify if…

• Participants who are pregnant or are currently breastfeeding
• History of sensitivity to study compound or any of their excipients
• Previous intolerance to SCFA or related compounds
• Current antibiotic treatment (within 3 months of screening) at discretion of PI
• Current consumption of probiotics (within 3 months of screening) at discretion of PI
• Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
• Renal failure (eGFR <30 or requiring dialysis) by history
• History of other autoimmune disease at discretion of PI
• Current immunodeficiency state (e.g., cancer, HIV, others)

Where it is running

• NYU Langone Health Orthopedic Center — New York, New York, United States

Full record on ClinicalTrials.gov

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