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临床试验/NCT03447093
NCT03447093Unknown不适用

The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年12月23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
120
试验地点
1
主要终点
Transcriptional changes in oral microbiota

研究概览

简要总结

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

详细描述

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

研究设计

研究类型
Observational
观察模型
Case Control
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
  • GD was clinical diagnosed and thyroid function returned to normal
  • HT was clinical diagnosed and thyroid function is normal.

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, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
  • History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
  • History of malignancy or any gastrointestinal tract surgery

研究组 & 干预措施

Drug treatment group

30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill

干预措施: Methimazole Pill (Drug)

Drug treatment group

30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill

干预措施: Propylthiouracil Pill (Drug)

结局指标

主要结局

Transcriptional changes in oral microbiota

时间窗: Baseline, 3 months, 6 months, 9 months, 12 months

The microbiota measured by 16S rRNA gene

次要结局

  • Serum thyroid function changed(Baseline, 3 months, 6 months, 9 months, 12 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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