EASi-RAIR: Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05718583
Collaborator
Arthritis Foundation (Other)
35
1
1
24
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Butyrate
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Butyrate; butyric acid
  • Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Microbiome Alpha Diversity [Baseline, Month 1 Post-Treatment Initiation]

      Measured by Shannon diversity index.

    Secondary Outcome Measures

    1. Change in Serum SCFA Concentration [Baseline, Month 1 Post-Treatment Initiation]

      Measured via participant blood draws.

    2. Change in Fecal SCFA Concentration [Baseline, Month 1 Post-Treatment Initiation]

      Measured via participant stool samples.

    3. Change in Peripheral Regulatory T Cell Concentration [Up to Month 1 Post-Treatment Initiation]

      Measured via participant blood draws.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Health Orthopedic Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • Arthritis Foundation

    Investigators

    • Principal Investigator: Rebecca Blank, MD, PhD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT05718583
    Other Study ID Numbers:
    • 22-01526
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NYU Langone Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2023