Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
| 适应症 | Rheumatoid Arthritis |
|---|---|
| 分期 | 不适用 |
| 申办方 | NYU Langone Health |
| 状态 | 已完成 |
| 受试者人数 | 20 人 |
| 干预（药物） | Butyrate |
| 开始日期 | 2023年2月1日 |
| 完成日期 | 2025年2月20日 |
| 结果公布日 | 2026年6月2日 |
摘要
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.
Change From Baseline in Microbiome Alpha Diversity
| RA Patients Who Are Inadequate Responders to Current RA Treatment | 0.19 index |
|---|
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- Dietary Salt in Rheumatoid Arthritis — Vanderbilt University Medical Center
- Feasibility and Acceptability of PREVAIL (PREserving Valued Activities In Life) — University of North Carolina, Chapel Hill
- Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With R — Alfasigma S.p.A.
- CD40L Antagonism in Rheumatoid Arthritis (RA) — National Institute of Allergy and Infectious Diseases (NIAID)
- A Study of Baricitinib in Participants With Rheumatoid Arthritis — Eli Lilly and Company
- A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis — Eli Lilly and Company