EUCTR2015-001248-12-IT进行中（未招募）1 期
Randomized crossover trial for the evaluation of the possible effects in the intestine of two different pharmaceutical forms of L - Thyroxine in patients with primary acquired hypothyroidism - Trial for the evaluation of the possible effects in the intestine of two different pharmaceutical fo
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Children with primary acquired hypothyroidism that require Levothyroxine therapy (naïve patients, < 18 years)
- •2. Informed consent from parents and patient
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age < 3 years
- •2. Patients with secondary hypothiroidism, euthyroid sick syndrome or thyroid ormone resistant
- •3. Patients with celiac diasease, type I diabetes or other known autoimmune diseases
- •4. Patients with genetic diseases or syndromes, such as Down, Williams-Beuren, Turner
- •5. Assumption of antibiotics, probiotics, prebiotics, or other medications that could affect the gut microbiota in the month before the beginning of the study
- •6. Gastrointestinal infectious diaseases in the month before the beginning of the study
- •7. Hypersensitivity to levothyroxine or any of the ingredients contained in the two pharmaceutical formulations
- •8. Untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis.
- •9. Patients with cardiovascular disease
- •10. Patients who show with impaired pancreatic function measured using the assay in faecal fat (steatocrit) at the screeening visit
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