This study is a pilot, proof of concept study to determine the effects of administering an oral short chain fatty acid (SCFA) supplement along with methotrexate as first line treatment of new onset rheumatoid arthritis (NORA) patients. Up to 50 participants will be included to obtain a sample size of at least 16 participants taking the oral supplement. The study team hypothesizes 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, 2 and 4 months with an optional 6-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
24
Butryate 1000 mg three times daily will be used in this study.
NYU Langone Health
New York, New York, United States
Change in Percentage of Circulating T Regulatory Cells (Treg)
Time frame: Baseline, Visit 2 (60 days)
Change in gut microbiota composition after SCFA supplementation
Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Change in Fecal SCFA Concentration after SCFA supplementation
Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation
Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)
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