Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change in WHO drinking levels by 1 or greater at month 3
研究概览
简要总结
The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.
详细描述
These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill").
Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups.
In this study, participants will be asked to do the following things:
- Visit VCU medical center up to 8 times for study visits
- Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month
- Have blood drawn, urine and stool collected at each visit
- Have testing done to determine the speed of brain function
- Keep a diary at home
- Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling.
- Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records.
Participation in this study will last up to 7 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Advanced liver disease
- •Able to give written, informed consent
- •Alcohol as a cause of advanced liver disease
- •Continued sustained drinking
- •Having previously declined a referral to traditional AUD therapy services or having failed such treatments
排除标准
- •Lack of sustained drinking
- •Recent or current alcoholic hepatitis
- •Alcohol withdrawal symptoms
- •Clinically significant use of illicit drugs
- •Uncontrolled mood disorders or primary psychotic conditions
- •MELD score>17
- •Unclear diagnosis of chronic liver disease
- •Current hepatic encephalopathy on lactulose and/or rifaximin
- •WBC count<1000
- •Non-elective hospitalization within last month
- •on dialysis
- •known untreated, in-situ luminal GI cancers
- •chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)
- •Dysphagia within 2 weeks
- •History of aspiration, gastroparesis, intestinal obstruction
- •Ongoing absorbable antibiotic use
- •Severe anaphylactic food allergy
- •allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
- •Adverse event attributable to prior IMT
- •ASA Class IV or V
- •Pregnant or nursing patients
- •acute illness or fever on the day of planned FMT
- •Immunosuppression
- •Other conditions which make patients are poor candidate for this study per investigator judgement
研究组 & 干预措施
Intestinal Microbiota Transplant capsules
Capsules will be provided twice during the trial
干预措施: Intestinal Microbiota Transplant (IMT) Capsules (Drug)
Placebo capsules
Capsules will be provided twice during the trial
干预措施: Placebo Capsules (Drug)
结局指标
主要结局
Change in WHO drinking levels by 1 or greater at month 3
时间窗: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
WHO grade by self report
Number of abstinent days
时间窗: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Number of drinks per day will be measured through self report
Reduction in WHO drinking levels by 1 or greater at month 3
时间窗: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
WHO grade by self report
Phosphatidyl Ethanol (PEth) level change
时间窗: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change to \<70
次要结局
- Number of hospitalizations(6 months)
- Number of serious adverse events(6 months)
- Change in microbial composition(Baseline to 3 months after treatment)
- Change in health related quality of live (HRQOL)(Baseline to 3 months after treatment)
- Change in percentage of heavy drinking days(Baseline to 3 months after treatment)
- Change in life problems(Baseline to 3 months after treatment)
- Change in Psychometric hepatic encephalopathy score (PHES)(Baseline to 3 months after treatment)
- Change in EncephalApp Stroop Test(Baseline to 3 months after treatment)
- Change in alcohol craving(Baseline to 3 months after treatment)
- Change in markers of alcohol in blood(Baseline to 3 months after treatment)
- Change in liver function(Baseline to 3 months after treatment)
- Change in markers of alcohol in urine(Baseline to 3 months after treatment)