A Comparison Study of Liver Fibrosis and Its Association With Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- The number of patients with advanced liver fibrosis or cirrhosis
研究概览
简要总结
While methotrexate (MTX) remains a treatment of choice for patients with rheumatoid arthritis (RA), psoriasis (PsO) and psoriatic arthritis (PsA), long-term MTX use has been shown to be associated with liver fibrosis and cirrhosis in these patients. In addition, gut dysbiosis has been found to be associated with liver fibrosis and cirrhosis via the gut-liver axis, underscoring the potential role of gut microbiota and bacterial translocation in the pathogenesis of chronic liver diseases in these patients.
In this study, we aim to assess the prevalence of advanced liver fibrosis or cirrhosis among these patients on MTX treatment compared to those without, using transient elastography. We also aim to identify the possible risk factor(s) for advanced liver fibrosis or cirrhosis among them. Further, we aim to characterize the difference in fecal microbiota patterns among these three groups of patients.
Using a cross-sectional, prospective cohort design, this study will enroll approximately 600 eligible patients, including 300 patients with PsO/PsA and 300 patients with RA, to examine the following hypotheses:
- Patients on higher cumulative dose of MTX will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those on lower cumulative dose of MTX;
- Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use;
- The fecal microbiota composition will be different between patients with and without MTX treatment; and
- The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 85 years
- •Have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital
- •Diagnosed with PsO/PsA or RA
- •Chinese ethnicity
排除标准
- •Age below 18 years or above 85 years
- •Known decompensated cirrhosis
- •Pregnancy or breastfeeding
- •Unstable medical illness or active infection
- •Unable to provide written consent
- •Unable to adhere to the protocol
- •Unable to read and/or write Chinese language
- •On anticoagulant/ antiplatelet treatment
- •Abnormal platelet count <150
- •Known disease/condition with prolonged INR/bleeding tendency
结局指标
主要结局
The number of patients with advanced liver fibrosis or cirrhosis
时间窗: At the time of the assessment procedure
We will measure the number of patients with significant fibrosis (defined as having liver stiffness ≥ 7.5 kPa in transient elastography), and among those who undergo biopsy, the number of patients whose biopsy specimen is of Roenigk grades 3b or 4
The type and abundance of fecal microbiota patterns
时间窗: At the time of the assessment procedure
We will measure the type and abundance of various bacteria/viruses in specimens; alpha diversity within a specimen and beta diversity between groups of specimen; specific taxa that differ significantly between groups; and metabolic profiles and functional pathways associated with change in gut microbiota
次要结局
- The risk factors of liver fibrosis(At the time of the assessment procedure)
研究者
Dr. Sze-Man Wong
Associate Consultant
Queen Mary Hospital, Hong Kong