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

NCT05152615 | Completed

• 1 other identifier: 20-02068
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Short Chain Fatty Acid (SCFA); Butyrate; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Circulating T Regulatory Cells (Treg)

  Baseline, Visit 2 (60 days)

Secondary Outcomes (3)

• 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)

Study Arms (1)

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.

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

Interventions

Short Chain Fatty Acids (SCFA) Dietary Supplement DIETARY_SUPPLEMENT

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

Also known as: Butyrate

New Onset Rheumatoid Arthritis (NORA) Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New diagnosis of rheumatoid arthritis (RA) (\<6 months) meeting 2010 ACR/EULAR for RA
• Scheduled to begin treatment with methotrexate at any dose as standard medical care
• Able and willing to provide written informed consent prior to any study specific procedures
• Age 18 years and above at time of enrollment
• Subjects not excluded based on race or ethnicity

You may not qualify if:

• Participants who are pregnant or are currently breastfeeding
• History of sensitivity to study compound or any of their excipients
• Previous intolerance to SCFA or related compounds
• Current (within 3 months of screening) treatment with csDMARDs
• Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23)
• Current antibiotic treatment (within 3 months of screening)
• Current consumption of probiotics (within 3 months of screening)
• Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
• Renal failure (eGFR \<30 or requiring dialysis) by history
• History of other autoimmune disease
• Current immunodeficiency state (e.g., cancer, HIV, others)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Fatty Acids, Volatile; Dietary Supplements; Butyrates

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jose Scher, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Rebecca B Blank, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 10, 2021
• Study Start: November 17, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)