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Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

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Conditions

Rheumatoid ArthritisShort Chain Fatty AcidButyrateMicrobiomeMethotrexate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2023-02-01
Study Completion:2025-02-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05718583

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
  2. 2. Inadequate response to MTX per treating MD at maximum tolerated dose.
  3. 3. Able and willing to provide written informed consent prior to any study specific procedures
  4. 4. Age 18 years and above at time of enrollment
  5. 5. Subjects not excluded based on race or ethnicity
  1. 1. Participants who are pregnant or are currently breastfeeding
  2. 2. History of sensitivity to study compound or any of their excipients
  3. 3. Previous intolerance to SCFA or related compounds
  4. 4. Current antibiotic treatment (within 3 months of screening) at discretion of PI
  5. 5. Current consumption of probiotics (within 3 months of screening) at discretion of PI
  6. 6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
  7. 7. Renal failure (eGFR \<30 or requiring dialysis) by history
  8. 8. History of other autoimmune disease at discretion of PI
  9. 9. Current immunodeficiency state (e.g., cancer, HIV, others)

Contacts and Locations

Principal Investigator

Rebecca Blank, MD, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2025-02-20

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2025-02-20

Terms related to this study

Keywords Provided by Researchers

  • Rheumatoid Arthritis
  • Short Chain Fatty Acid
  • Butyrate
  • Microbiome
  • Methotrexate

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis