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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Dietary Supplement: Short Chain Fatty Acids (SCFA) Dietary Supplement

• Registration Number: NCT05152615
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-17
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-10
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New Onset Rheumatoid Arthritis (NORA) Patient	Short Chain Fatty Acids (SCFA) Dietary Supplement	NORA patients receiving methotraxate as first line therapy (standard of care) will take additional oral SCFA supplementation for the purposes of the study.

Primary Outcome Measures

Name	Time	Method
Change in Percentage of Circulating T Regulatory Cells (Treg)	Baseline, Visit 2 (60 days)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States