Your session is about to expire
← Back to Search
Butyrate for Rheumatoid Arthritis (EASi-RAIR Trial)
N/A
Recruiting
Led By Rebecca Blank, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 1 post-treatment initiation
Awards & highlights
EASi-RAIR Trial Summary
This trial will test if taking a supplement can improve RA symptoms by changing the gut microbiome & immune system of patients not responding to methotrexate.
Who is the study for?
This trial is for adults over 18 with Rheumatoid Arthritis who haven't had enough relief from methotrexate. It's not for those with severe liver problems, kidney failure, immune deficiencies like cancer or HIV, pregnant or breastfeeding women, previous SCFA intolerance, recent antibiotic or probiotic use.Check my eligibility
What is being tested?
The study tests if an oral supplement of short-chain fatty acids (SCFAs) can help people with Rheumatoid Arthritis by changing their gut bacteria and immune response. Up to 35 participants will take the supplement alongside regular blood, stool, and urine tests over up to two months.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include digestive discomfort due to SCFA intake and possible reactions related to changes in the gut microbiome or immune system.
EASi-RAIR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 1 post-treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 1 post-treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Microbiome Alpha Diversity
Secondary outcome measures
Change in Fecal SCFA Concentration
Change in Peripheral Regulatory T Cell Concentration
Change in Serum SCFA Concentration
EASi-RAIR Trial Design
1Treatment groups
Experimental Treatment
Group I: RA Patients who are Inadequate Responders to Current RA TreatmentExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Butyrate
2021
N/A
~250
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,691 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
396 Patients Enrolled for Rheumatoid Arthritis
Arthritis FoundationOTHER
34 Previous Clinical Trials
46,116 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
1,541 Patients Enrolled for Rheumatoid Arthritis
Rebecca Blank, MD, PhDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on antibiotics in the last 3 months, as decided by my doctor.I have severe kidney problems or am on dialysis.I have severe liver problems, including fluid in the abdomen or bleeding issues.I have a condition that weakens my immune system.I have been diagnosed with rheumatoid arthritis by my doctor.My condition did not improve after taking the highest dose of methotrexate I could tolerate.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: RA Patients who are Inadequate Responders to Current RA Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants still being admitted to this research project?
"Yes, according to clinicaltrials.gov, this trial is still seeking participants and has been since February 1st 2023 when it was initially posted. The most recent update of the study occurred on August 2nd 2023 and 35 volunteers are necessary at a single site."
Answered by AI
What is the present number of participants involved in this clinical trial?
"Affirmative. According to data published on clinicaltrials.gov, this medical trial is presently accepting participants. This study was first posted on February 1st 2023 and has been revised as recently as the 8th of that same month. A total of 35 patients are needed from a single location for completion of the research."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger