NL-OMON48031招募中不适用
Effect of donor Intestinal Microbiota Infusion on Thyroid function in patients with autoimmune HypOThyreoidism - IMITHOT-trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Newly diagnosed patients with subclinical autoimmune hypothyroidism aged 18-70 years,
- •TSH > 10 mU/L
- •BMI 18-30 kg/m2,
- •male/females,
- •no concomitant medication,
- •antiTPO positive and increased TSH (above 5.0mE/L) with FT4 within normal reference value ;feces donoren:
- •Healthy male/female volunteers
- •aged 18-70 years,
- •BMI 18-28 kg/m2,
- •no medication use,
- •no family history of autoimmune diseases
排除标准
- •concomitant medication including PPI and antibiotics past three months,
- •(expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).;fecal donors:
- •1. (chronic) diarrhoea
- •2. family history of autoimmune diseases (type 1 diabetes, Hashimoto hypothyreoidism, Graves hyperthyreoidism, rheumatoid arthritis, inflammatory bowel diseases eg. Crohn*s disease, Colitus ulcerosa or coeliakie)
- •3. HIV, HAV, HBV, HCV, active CMV, active EBV
- •4. Unsafe sex practice (questionnaire)
- •5. presence of fecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia) or parasites
- •6. positive C. difficile stool test
- •7. any medication use including PPI and antibiotics
- •8. smoking
研究者
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