Clinical Trial Finder

Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis. 2. Inadequate response to MTX per treating MD at maximum tolerated dose. 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 antibiotic treatment (within 3 months of screening) at discretion of PI. 5. Current consumption of probiotics (within 3 months of screening) at discretion of PI. 6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 7. Renal failure (eGFR <30 or requiring dialysis) by history. 8. History of other autoimmune disease at discretion of PI. 9. Current immunodeficiency state (e.g., cancer, HIV, others)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05718583
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rebecca Blank, MD, PhD
Principal Investigator Affiliation NYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis
Arms & Interventions

Arms

Experimental: RA Patients who are Inadequate Responders to Current RA Treatment

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

Dietary Supplement: - Butyrate

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

NYU Langone Health Orthopedic Center, New York, New York

Status

Recruiting

Address

NYU Langone Health Orthopedic Center

New York, New York, 10016

Powered By