EUCTR2017-003629-13-GB进行中（未招募）1 期
A Prospective, randomised placebo controlled feasibility trial of Faecal Microbiotica Transplantation in cirrhosis - PROFIT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- •18–75 years
- •Confirmed advanced cirrhosis of any aetiology with a MELD score between 10 and 16. The diagnosis of liver cirrhosis will be based on clinical, radiological, or histological criteria.
- •Patients with alcohol-related liver disease must have been abstinent from alcohol for a minimum of 6 weeks.
- •Patients must be deemed to have capacity to consent to study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Severe or life-threatening food allergy
- •Pregnancy or breastfeeding
- •Patients treated for active variceal bleeding, infection, bacterial peritonitis, overt hepatic encephalopathy or acute-on-chronic liver failure within the past 14 days.
- •Patients who have received antibiotics in the past 14 days.
- •Active alcohol consumption of >20 grams/day.
- •Has had a previous liver transplant
- •Hepatocellular carcinoma outside of the Milan Criteria (2)
- •A history of prior gastrointestinal resection such as gastric bypass
- •Patient is not expected to survive the duration of the study (90 days).
- •Severe renal impairment (creatinine >150 µmol/L)
- •Inflammatory bowel disease (IBD)
- •Coeliac disease
- •HIV positive
- •Immunosuppression e.g. more than two weeks treatment with corticosteroids within 8 weeks of intervention, active treatment with tacrolimus, mycophenylate, azathioprine
研究者
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