Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Description

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.

Conditions

Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

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.

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)

Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health Orthopedic Center, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Rebecca Blank, MD, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-02-01