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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
NYU Langone Health Orthopedic Center
New York, New York, United States
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.
Time frame: Baseline, Month 1 Post-Treatment Initiation
Change in Serum SCFA Concentration
Measured via participant blood draws.
Time frame: Baseline, Month 1 Post-Treatment Initiation
Change in Fecal SCFA Concentration
Measured via participant stool samples.
Time frame: 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.
Time frame: Baseline, Month 1 Post-Treatment Initiation
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