FMT for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks
研究概览
简要总结
- Title "FMT for Alcohol Use Disorder in cirrhotics: A Randomized Controlled Trial"
- The aim of the study is to study the efficacy of Fecal microbiota transplantation in patients with Alcohol liver disease over a 6 month duration without liver related side effects. The project will be conducted at ILBS over the period of 1 year.
- The concept is to test the efficacy of FMT in alcohol related cirrhotics by its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.
详细描述
Hypothesis :- - FMT is useful in reducing craving and return to heavy drinking in patients with alcohol related cirrhosis with active drinking, through modulation of gut microbiota and correction of dysbiosis
Aim and Objective -
- To assess the efficacy of FMT in decreasing lapse, relapses and maintaining alcohol abstinence in AUD in patients with cirrhosis
Study population:
- Patients with cirrhosis with recent alcohol use attending outpatient clinic at ILBS, New Delhi
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with alcohol related cirrhosis with serum bilirubin <5mg/dl with an active alcohol consumption atleast within last 4 weeks aged between 18 -70yrs.
- •Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).
排除标准
- •Acute illness or fever on the day of planned FMT
- •Ongoing/Past 2 weeks antibiotic use
- •Unclear diagnosis of CLD
- •Non-elective hospitalization within last month
- •Serum bilirubin >5mg/dl
- •Grade 2 or more Ascites
- •Any Episode of HE Grade 2 or more or requiring hospital admission within 3 months
- •Episode of AVB within last 3 months
- •Treatment with corticosteroids/Immunosupression within the past 60 days
- •Unwilling to participate
- •Dependence on any other substance (except Nicotine)
- •Psychiatric disorder requiring pharmacotherapy/Suicidal tendency
- •Known untreated, in-situ luminal GI cancers & chronic intrinsic GI diseases.
研究组 & 干预措施
FMT + SMT
Therapy with Fecal microbiota transplantation with SMT (Baclofen + AUD counselling). - Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4.
干预措施: SMT (Other)
Placebo + SMT
Placebo therapy with SMT (Baclofen + AUD counselling)
干预措施: SMT (Other)
Placebo + SMT
Placebo therapy with SMT (Baclofen + AUD counselling)
干预措施: Placebo (Other)
FMT + SMT
Therapy with Fecal microbiota transplantation with SMT (Baclofen + AUD counselling). - Single dose (30gm/90ml) of FMT will be given via upper GI gastroduodenoscope at D4.
干预措施: FMT (Biological)
结局指标
主要结局
Proportion of patients achieving and maintaining alcohol abstinence at 4 weeks
时间窗: 4 weeks
次要结局
- Gut microbiome alterations and relative abundance of gut associated bacteria.(12 weeks)
- Proportion of patients maintaining abstinence from alcohol at 3 & 6 months.(3 and 6 months)
- Craving measures will be assessed based on pre-existing structured and validated questionnaires (Obsessive Compulsive Drinking Scale (OCDS) and Visual Analog Scale (VAS).(4,12 weeks and 6 months)
- Proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.(4,12 weeks and 6 months.)
- Proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.(12 weeks)