ISRCTN14379650进行中（未招募）未知
Fatigue in primary biliary cholangitis: factors associated with severity and persistence as future therapeutic targets
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 480 人开始时间: 2021年11月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36600365/ (added 06/01/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Clinical diagnosis of PBC (PSC)
- •2. Sufficient oral and written German language proficiency
- •3. Provision of written consent
排除标准
- •1. Advanced cirrhosis (Child Pugh score =8)
- •2. Decompensated liver disease (autoimmune hepatitis or chronic viral hepatitis B or C)
- •3. Clinically significant untreated intercurrent medical condition associated with fatigue (i.e. hypothyroidism, anaemia, fibromyalgia, rheumatoid arthritis, systemic lupus erythematosus and manifest depression)
- •4. Antibiotic treatment during the past 6 weeks (exclusion only in microbiome study)
- •5. Ongoing participation in clinical trials on fatigue
- •6. Intercurrent active or latent infection
- •7. Florid psychosis
- •8. Substance abuse disorder
- •9. Acute suicidality
研究者
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Unknown
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