NCT05152615

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Short Chain Fatty Acids (SCFA) Dietary Supplement	Butryate 1000 mg three times daily will be used in this study.

Timeline

• Start date: 2021-11-17
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2021-12-10
• Last updated: 2024-06-24

Locations

1 site across 1 country: United States