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临床试验/NCT03390582
NCT03390582Unknown不适用

Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月20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
发起方
入组人数
200
试验地点
1
主要终点
16S rRNAgene sequencing was used to measure the diversity of gut microbiota

研究概览

简要总结

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

详细描述

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features,and the disease may progress from one state to another as the autoimmune process evolves. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 65 years
  • Male or female gender
  • Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy)

排除标准

  • Pregnancy
  • Lactation
  • Cigarette smoking
  • Alcohol addiction
  • Hypertension
  • Diabetes mellitus
  • Lipid dysregulation
  • BMI > 27
  • Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
  • Known history of disease with an autoimmune component such as MS, rheumatoid arthritis, IBS, and IBD
  • History of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).

研究组 & 干预措施

treated GD

GD patients treated by Methimazole Pill

干预措施: Methimazole Pill (Drug)

结局指标

主要结局

16S rRNAgene sequencing was used to measure the diversity of gut microbiota

时间窗: HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal

Intestinal microbes are different in different groups

次要结局

  • Thyroid function tested by Chemiluminescence method(Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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