Rheumatoid ArthritisEASi-RAIRNCT05718583
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
A study testing Butyrate in people with Rheumatoid Arthritis, run by NYU Langone Health at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 20 Feb 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Health Orthopedic Center
New York, New York, 10016
About this study
Official title: 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 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Butyrate
- Keywords
- Rheumatoid Arthritis, Short Chain Fatty Acid, Butyrate, Microbiome, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButyrateDietary supplement
Also called Butyrate; butyric acid
Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
| Study group | Role | What they receive |
|---|---|---|
| RA Patients who are Inadequate Responders to Current RA Treatment | Experimental | 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. Receives: Dietary Supplement: Butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Microbiome Alpha Diversity
Change in alpha diversity by Shannon Entropy of the gut microbiota after taking butyrate supplement for one month was measured. Alpha diversity by Shannon Entropy quantifies the complexity of a single community by accounting for both species richness (total number of types) and species evenness (distribution of abundance). It calculates the uncertainty of predicting the identity of an individual picked at random, where higher entropy implies higher diversity.
Measured: Baseline, Month 1 Post-Treatment Initiation
Secondary outcomes (3)
Change in Serum SCFA Concentration
Measured via participant blood draws.
Measured: Baseline, Month 1 Post-Treatment Initiation
Change in Fecal SCFA Concentration
Measured via participant stool samples.
Measured: Baseline, Month 1 Post-Treatment Initiation
Change in Peripheral Regulatory T Cell Concentration
Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention.
Measured: Baseline, Month 1 Post-Treatment Initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Sponsor
- Investigators
- Jose Scher, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718583
- Sponsor's protocol ID
- 22-01526
- Acronym
- EASi-RAIR
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2023
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[Rebecca.blank@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.