NCT04758806Unknown3 期
Fecal Microbial Transplantation for Corticosteroids Non-responders and Non-eligible Patients With Severe Alcoholic Hepatitis
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
- A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019)
- The only SAH treatment option - corticosteroids (CS) - are often contraindicated or ineffective (STOPAH Trial)
- New treatment modalities for remaining patients are much needed
- Fecal microbial transplantation (FMT) is one of the promising therapies
- Investigators aimed to see if FMT improves survival in patients admitted with SAH, not responding to-, or non-eligible for CS.
详细描述
- FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model).
- Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consenting, adult
- •severe form of acute alcoholic hepatitis (SAH)
- •non-responder to corticosteroids according to the Lille model
- •patients with SAH not eligible for corticosteroids based on their contraindications
排除标准
- •active infection
- •presence of untreated large / high-risk / bleeding esophageal varices
- •too sick for any therapy / futility (chronic extrahepatic organ failures, no potential for recovery, etc)
- •malignancy except for hepatocellular carcinoma in Milan criteria
结局指标
主要结局
Mortality
时间窗: 1 year
Overall mortality
次要结局
- Acute on chronic liver failure(In-Hospital)
研究者
Ľubomír Skladaný MD, PhD
Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
研究点 (2)
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