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NCT Number: NCT05718583

Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health Orthopedic Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Butyrate

Dietary Supplement

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.

Other names: Butyrate; butyric acid

Primary outcomes

  1. Change From Baseline in Microbiome Alpha Diversity

    Time frame: Baseline, Month 1 Post-Treatment Initiation

    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.

Secondary outcomes

  1. Change in Serum SCFA Concentration

    Time frame: Baseline, Month 1 Post-Treatment Initiation

    Measured via participant blood draws.

  2. Change in Fecal SCFA Concentration

    Time frame: Baseline, Month 1 Post-Treatment Initiation

    Measured via participant stool samples.

  3. Change in Peripheral Regulatory T Cell Concentration

    Time frame: Baseline, Month 1 Post-Treatment Initiation

    Measured via participant blood draws. Percentage of peripheral regulatory T cells were determined by flow cytometry at baseline and 1 month after intervention.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Arthritis Foundation

Registry information

Official study 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)

Acronym: EASi-RAIR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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