Fecal Microbiota Transplant for Alcohol Use Disorder in Cirrhotics: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To assess proportion of patients achieving and maintaining alcohol abstinence at 4 weeks
研究概览
简要总结
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Title “FMT for Alcohol Use Disorder in cirrhotics: A Randomized Controlled Trialâ€
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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.
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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.
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
Study design:
- Open label, parallel group, randomized, controlled study.
Study period:
- 1 year
Sample size with justification:
- Assuming that abstinence in Placebo group is 50% and we assume that there will be 40% absolute increase in FMT group (90%; Bajaj JS, Hepatology 2021) with alpha 5 and power of 80% we need to enroll 48 cases, further assuming 10 % dropout rate it was decided to enroll 54 cases that is 27 in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients with alcohol related cirrhosis with serum bilirubin less than 5mg per 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
- •Pregnancy
- •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 more than 5mg per dl
- •Grade 2 or more Ascites
- •Any Episode of HE Grade 2 or more or requiring hospital admission within 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.
结局指标
主要结局
To assess proportion of patients achieving and maintaining alcohol abstinence at 4 weeks
时间窗: 4 weeks
次要结局
- Changes in microbiota and mucosal composition and diversity at 12 weeks.(12 weeks)
- To assess proportion of patients who got FMT at 12 weeks without liver related adverse effects compared to placebo.(12 weeks)
- To assess proportion of patients maintaining abstinence from alcohol at 3 & 6 months.(3 & 6 months)
- To assess difference in craving measures between groups at 4,12 weeks and 6 months(4,12 weeks and 6 months)
- To assess proportion of patients developing lapse and relapse at 4,12 weeks and 6 months.(4,12 weeks and 6 months)
研究者
Dr Srajit Singh
Institute of Liver and Biliary Sciences