A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change of gut microbiome in the treatment of Graves' disease
研究概览
简要总结
Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of 0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea. However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. Therefore it is essential to distinguish between patients who respond well to ATD and those who resist it. The aim of this study is to verify the changes in gut microbiome in Graves' disease patients before and after six-month treatment with ATD. Patients first diagnosed with Graves' disease will participate in the study. The study design is a prospective longitudinal trial. The patients are asked to have their gut microbiome analyzed before and after the treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut microbiome before and after ATD treatment. Secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to ATD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 69 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 19 years and lesser than 70 years
- •First diagnosed as Graves' disease and planned to have antithyroid drug
排除标准
- •Pregnancy and lactating women
- •Inflammatory bowel disease
- •Active malignancy
- •Autoimmune disease
- •Immune-deficiency patients
研究组 & 干预措施
Graves' disease patients
First diagnosed Graves' disease patients volunteered for stool collection
干预措施: Antithyroid Drug (Drug)
结局指标
主要结局
Change of gut microbiome in the treatment of Graves' disease
时间窗: 6 months after treatment
Analysis of gut microbiome before and after treatment of Graves' disease with antithyroid drug
次要结局
未报告次要终点
研究者
Dong Jun Lim
Professor in Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
