Rheumatoid Arthritis
Conditions
Keywords
Short Chain Fatty Acid (SCFA), Butyrate, Gut Microbiome
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTShort Chain Fatty Acids (SCFA) Dietary Supplement
Butryate 1000 mg three times daily will be used in this study.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. New diagnosis of rheumatoid arthritis (RA) (\<6 months) meeting 2010 ACR/EULAR for RA 2. Scheduled to begin treatment with methotrexate at any dose as standard medical care 3. Able and willing to provide written informed consent prior to any study specific procedures 4. Age 18 years and above at time of enrollment 5. Subjects not excluded based on race or ethnicity
Exclusion criteria
1. Participants who are pregnant or are currently breastfeeding 2. History of sensitivity to study compound or any of their excipients 3. Previous intolerance to SCFA or related compounds 4. Current (within 3 months of screening) treatment with csDMARDs 5. Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23) 6. Current antibiotic treatment (within 3 months of screening) 7. Current consumption of probiotics (within 3 months of screening) 8. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 9. Renal failure (eGFR \<30 or requiring dialysis) by history 10. History of other autoimmune disease 11. Current immunodeficiency state (e.g., cancer, HIV, others)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Percentage of Circulating T Regulatory Cells (Treg) | Baseline, Visit 2 (60 days) |
Secondary
| Measure | Time frame |
|---|---|
| Change in gut microbiota composition after SCFA supplementation | Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) |
| Change in Fecal SCFA Concentration after SCFA supplementation | Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) |
| Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation | Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) |
Countries
United States
Outcome results
None listed