The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Transcriptional changes in gut microbiota
研究概览
简要总结
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.
详细描述
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.
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
- 是
入选标准
- •Aged 18 to 65 years
- •GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to 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
Recrudescence group
30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
干预措施: Methimazole Pill (Drug)
Recrudescence group
30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
干预措施: Propylthiouracil Pill (Drug)
No recrudescence group
30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
干预措施: Methimazole Pill (Drug)
No recrudescence group
30 GD patients who did not receive recurrence within 2 years after 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 gut microbiota
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
The microbiota measured by 16S rRNA gene
次要结局
- Serum thyroid function changed(Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal)