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

A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Dietary supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement; Butryate 1000 mg three times daily will be used in this study.; Other Names: Butyrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Percentage of Circulating T Regulatory Cells (Treg)	Baseline, Visit 2 (60 days)

Secondary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Rebecca B Blank, MD, PhD, NYU Langone Health; Principal Investigator: Jose Scher, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Butyrate; Gut Microbiome; Short Chain Fatty Acid (SCFA)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 20-02068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No