NCT05718583Completed
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
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)
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 30 Jan 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 20 Feb 2025
- Lead sponsor
- NYU Langone Health
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05718583
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Feb 2023 to the primary completion date, 20 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intolerance to SCFA or related compounds
Other illness
- History of sensitivity to study compound or any of their excipients
- Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- History of other autoimmune disease at discretion of PI
- Current immunodeficiency state (e.g., cancer, HIV, others)
Lab values
- Renal failure (eGFR \<30 or requiring dialysis) by history
Other
- Participants who are pregnant or are currently breastfeeding
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Orthopedic Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.