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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Onset Rheumatoid Arthritis (NORA) Patient | Experimental | NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Chain Fatty Acids (SCFA) Dietary Supplement | Dietary Supplement | Butryate 1000 mg three times daily will be used in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Circulating T Regulatory Cells (Treg) | Baseline, Visit 2 (60 days) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Scher, MD | NYU Langone Health | Principal Investigator |
| Rebecca B Blank, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Rebecca.Blank@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005232 | Fatty Acids, Volatile |
| D019587 | Dietary Supplements |
| D002087 | Butyrates |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation | Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |