A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) in Rheumatoid Arthritis (EASi-RA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Percentage of Circulating T Regulatory Cells (Treg)
研究概览
简要总结
This study is a pilot, proof of concept study to determine the effects of administering an oral short chain fatty acid (SCFA) supplement along with methotrexate as first line treatment of new onset rheumatoid arthritis (NORA) patients. Up to 50 participants will be included to obtain a sample size of at least 16 participants taking the oral supplement. The study team hypothesizes 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, 2 and 4 months with an optional 6-month time point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of rheumatoid arthritis (RA) (<6 months) meeting 2010 ACR/EULAR for RA
- •Scheduled to begin treatment with methotrexate at any dose as standard medical care
- •Able and willing to provide written informed consent prior to any study specific procedures
- •Age 18 years and above at time of enrollment
- •Subjects not excluded based on race or ethnicity
排除标准
- •Participants who are pregnant or are currently breastfeeding
- •History of sensitivity to study compound or any of their excipients
- •Previous intolerance to SCFA or related compounds
- •Current (within 3 months of screening) treatment with csDMARDs
- •Current or past (ever) treatment with biologic therapies (including but not limited to anti-TNF, anti-IL-17, anti-IL-12/23)
- •Current antibiotic treatment (within 3 months of screening)
- •Current consumption of probiotics (within 3 months of screening)
- •Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- •Renal failure (eGFR <30 or requiring dialysis) by history
- •History of other autoimmune disease
- •Current immunodeficiency state (e.g., cancer, HIV, others)
结局指标
主要结局
Change in Percentage of Circulating T Regulatory Cells (Treg)
时间窗: Baseline, Visit 2 (60 days)
次要结局
- Change in gut microbiota composition after SCFA supplementation(Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days))
- Change in Fecal SCFA Concentration after SCFA supplementation(Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days))
- Change in Interleukin-10 (IL-10) Production Levels after SCFA Supplementation(Baseline, Visit 2 (60 days), Visit 3 (120 days), Visit 4 (180 days))