At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria or treating physician diagnosis
- ✓Inadequate response to methotrexate at maximum tolerated dose per treating physician
- ✓Age 18 years or older at enrollment
- ✕Pregnancy or currently breastfeeding
- ✕History of sensitivity or intolerance to butyrate or SCFA-related compounds
- ✕Current antibiotic treatment within 3 months of screening (at PI discretion)
- ✕Current consumption of probiotics within 3 months of screening (at PI discretion)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) Supplement in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)
In Brief
A clinical study evaluating Butyrate for Rheumatoid Arthritis. Completed, enrolled 20 participants across 1 site.
Signals
Detailed Summary
This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize 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, 1 month, and with an optional 2 month time-point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.
Study Details
Timeline
Arms & Interventions
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2-month time-point.
Interventions
Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.