EASi-RAIR: Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: RA Patients who are Inadequate Responders to Current RA Treatment 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. |
Dietary Supplement: Butyrate
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:
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Outcome Measures
Primary Outcome Measures
- Change from Baseline in Microbiome Alpha Diversity [Baseline, Month 1 Post-Treatment Initiation]
Measured by Shannon diversity index.
Secondary Outcome Measures
- Change in Serum SCFA Concentration [Baseline, Month 1 Post-Treatment Initiation]
Measured via participant blood draws.
- Change in Fecal SCFA Concentration [Baseline, Month 1 Post-Treatment Initiation]
Measured via participant stool samples.
- Change in Peripheral Regulatory T Cell Concentration [Up to Month 1 Post-Treatment Initiation]
Measured via participant blood draws.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
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Inadequate response to MTX per treating MD at maximum tolerated dose.
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Able and willing to provide written informed consent prior to any study specific procedures
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Age 18 years and above at time of enrollment
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Subjects not excluded based on race or ethnicity
Exclusion Criteria:
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Participants who are pregnant or are currently breastfeeding
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History of sensitivity to study compound or any of their excipients
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Previous intolerance to SCFA or related compounds
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Current antibiotic treatment (within 3 months of screening) at discretion of PI
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Current consumption of probiotics (within 3 months of screening) at discretion of PI
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Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
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Renal failure (eGFR <30 or requiring dialysis) by history
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History of other autoimmune disease at discretion of PI
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Current immunodeficiency state (e.g., cancer, HIV, others)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | NYU Langone Health Orthopedic Center | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- Arthritis Foundation
Investigators
- Principal Investigator: Rebecca Blank, MD, PhD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-01526