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临床试验/NCT04383795
NCT04383795已完成不适用

A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年5月19日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Jun Lim

Professor in Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital

Seoul St. Mary's Hospital

研究点 (1)

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