A Pilot Study to Evaluate Efficacy and Safety of Butyrate Supplement in the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in disease Activity Score in 28 joints (DAS28)
研究概览
简要总结
This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Thirty participants will be included to receive butyrate supplement for 12 weeks. Changes of immune cell subtypes, markers of intestinal damage, intestinal flora and other laboratory indicators will be monitored.
详细描述
This is a single center, uncontrolled, open-label study to assess the efficacy and safety of butyrate supplement plus standard therapy in rheumatoid arthritis(RA). The patients will be given 2 sodium butyrate capsules (containing 1200 mg of sodium butyrate) daily as supplemental therapy. The objective is to assess the effects of 12 weeks of sodium butyrate supplementation on intestinal inflammation and immune regulation in patients with RA, specifically changes in T-cell subtypes and biomarkers associated with intestinal injury. Clinical manifestations and other laboratory indices will also be monitored.
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
- •Male or female ≥18 years of age at the time of screening, weight≥35 kg.
- •Diagnosed with rheumatoid arthritis satisfying the 1987 American College of Rheumatology classification criteria.
- •Stable treatment, including DMARDs (disease-modifying anti-rheumatic drugs) and glucocorticoids, was stable in dose for at least 4 weeks, and no biological agents were used during the first 12 weeks of enrollment.
- •Have given written informed consent
排除标准
- •Patient presenting or having a history of other autoimmune diseases (such as Sjogren's syndrome, systemic lupus erythematosus, systemic sclerosis, vasculitis, etc.) and other arthritic diseases (such as spinal arthritis, psoriatic arthritis, reactive arthritis, etc.)
- •Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- •Patient with significantly impaired bone marrow function or significant anemia, leucopenia or thrombocytopenia induced by other disease
- •Patient with persistent or severe infection within 3 months before enrollment
- •Patient with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which would put the patient at risk of participating in the study according to the opinion of investigator
- •Patient with cardiovascular, hepatic, neurological, endocrine, or other major systemic disease, which may make implementation of the protocol or interpretation of the study results difficult
- •Patient who has severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome), with serum albumin < 30 g/L)
- •Patient who has moderate or severe impairment of renal function (the estimated glomerular filtration rate was < 60 mL/min/1.73 m2)
- •Patient with impairment of liver function or persisting Alanine transaminase (ALT) or Aspartate aminotransferase (AST) elevations of more than 2-fold the upper limit of normal
- •Patient with Known HIV positive status or positive serology for hepatitis B or C
- •Pregnant or breastfeeding woman
- •Women of childbearing potential
- •Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 months with the washout procedure)
- •Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation.
- •Patient who enrolled in any other clinical trial involving off-label use of an investigational drug or device, or any other type of medical research
- •Patient using any biologic agent such as anti-tumor necrosis factor, IL-6 receptor antagonist, anti-CD20 monoclonal antibody within 3 months prior to the first dose of treatment.
- •Patient whose BMI (body mass index) is under 18.5 kg/m2 or more than 30 kg/m2
- •Patient with history of drug or alcohol abuse
研究组 & 干预措施
Butyrate supplement
2 capsules butyrate supplement (containing 1200 mg of butyric acid ) once a day for 12 weeks Drug: sodium butyrate
干预措施: Sodium Butyrate (Drug)
结局指标
主要结局
Changes in disease Activity Score in 28 joints (DAS28)
时间窗: Baseline,12 weeks
Evaluating changes in DAS28 before and after treatment. DAS28 was calculated by the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (mm/h) or c-reactive protein (CRP) (mg/L), and patient's global assessment (PGA) of disease activity (based on the visual analog score \[VAS\], 0-100mm). Compared with the baseline, a lower DAS28 would mean an improvement in disease activity. Conversely, an increase in DAS28 indicates a deterioration in disease activity.
次要结局
- Changes in the simplified disease activity index (SDAI)(Baseline and 12 weeks)
- Changes in the clinical disease activity index (CDAI)(Baseline and 12 weeks)
- Changes in T cell subtypes.(Baseline, 4 weeks and 12 weeks)
- Changes in c-reactive protein (CRP).(Baseline, 4 weeks and 12 weeks)
- Changes in erythrocyte sedimentation rate (ESR).(Baseline, 4 weeks and 12 weeks)
- Changes in serum lipopolysaccharide-binding protein (LBP)(Baseline, 4 weeks and 12 weeks)
- Changes in serum intestinal fatty acid-binding protein (I-FABP)(Baseline, 4 weeks and 12 weeks)
- Changes in serum soluble cluster of differentiation 14 (sCD14)(Baseline, 4 weeks and 12 weeks)
- Numbers of participants with treatment-related adverse events(12 weeks)
研究者
Zhanguo Li
Professor
Peking University People's Hospital