A Pilot Proof of Concept Study of the Effects of Administration of SCFA in Rheumatoid Arthritis (EASi-RA)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05152615
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jose Scher, MDRebecca B Blank, MD, PhD
Principal Investigator Affiliation	NYU Langone HealthNYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Arms & Interventions

Arms

Experimental: New Onset Rheumatoid Arthritis (NORA) Patient

NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.

Interventions

Dietary Supplement: - Short Chain Fatty Acids (SCFA) Dietary Supplement

Butryate 1000 mg three times daily will be used in this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Site Contact

Rebecca B Blank, MD, PhD

[email protected]

212-501-7642

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