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NCT Number: NCT05152615

A Pilot Proof of Concept Study of the Effects of Administration of 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Short Chain Fatty Acids (SCFA) Dietary Supplement

Dietary Supplement

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

Other names: Butyrate

Primary outcomes

  1. Change in Percentage of Circulating T Regulatory Cells (Treg)

    Time frame: Baseline, Visit 2 (60 days)

Secondary outcomes

  1. Change in gut microbiota composition after SCFA supplementation

    Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)

  2. Change in Fecal SCFA Concentration after SCFA supplementation

    Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)

  3. Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation

    Time frame: Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2021
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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