Effects of Probiotic Supplementation in Alcohol Use Disorder: A Randomised, Placebo-Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling
研究概览
简要总结
Alcohol Use Disorder (AUD) is a common condition that can affect physical and mental health. Current treatments do not work for everyone, and new approaches are needed.
The primary aim of this study is to assess whether taking a specific probiotic supplement (a type of "good bacteria") is a feasible approach for people with AUD - that is, whether it is practical, acceptable, and well-tolerated within this population. As a secondary aim, the study also explores whether the probiotic may help improve psychological, biological, and cognitive wellbeing.
Participants are randomly assigned to receive either a probiotic supplement or a placebo (a capsule with no active ingredients) for four weeks. Neither the participants nor the researchers know which treatment is given during the study.
The aim is to understand whether probiotics could be a feasible and helpful additional approach to support people with AUD.
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
- •A self-reported history of heavy drinking
- •At least one heavy drinking episode (≥8 units) in the last 28 days
排除标准
- •Participants being under 18 years of age
- •Supplementation of probiotics or prebiotics within the past 4 weeks
- •Antibiotic use within the past 4 weeks
- •Major psychiatric conditions diagnosed e.g., bipolar disorder, schizophrenia
- •Current pregnancy or breastfeeding
- •Having had a heavy drinking episode (≥8 units) in the last 12 hours
研究组 & 干预措施
Probiotic Group
Capsules contain the active ingredient (live bacteria)
干预措施: Probiotic Formula Capsule (Dietary Supplement)
Placebo Group
Capsules look identical to the probiotic but contain no live bacteria
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Recruitment Rate, Defined as the Proportion of Screened Participants Meeting Eligibility Criteria and Enrolling
时间窗: From enrollment to the end of treatment at 4 weeks
Recruitment rate will be calculated as the number of participants enrolled divided by the total number of participants assessed for eligibility, expressed as a percentage.
Retention Rate, Defined as the Proportion of Enrolled Participants Completing the 4-Week Intervention
时间窗: From enrollment to the end of treatment at 4 weeks
Retention rate will be calculated as the number of participants completing the 4-week intervention divided by the total number enrolled, expressed as a percentage, and will be reported overall and by study arm.
Intervention Adherence, Assessed by Capsule Count
时间窗: From enrollment to the end of treatment at 4 weeks
Adherence will be calculated as the number of capsules consumed relative to the 28 capsules prescribed across the 4-week intervention period, based on participant-reported capsule counts, and expressed as a percentage of the total prescribed dose.
Participant Acceptability, Assessed by Verbal Feedback
时间窗: From enrollment to the end of treatment at 4 weeks
Acceptability of the intervention will be assessed via verbal feedback requested from the participants at the end of the 4-week intervention period, covering participants' experience of intervention components including capsule-taking and stool sample collection procedures.
次要结局
- 38 participants with Alcohol Use Disorder assessed for Depression, Anxiety, and Stress by Depression Anxiety Stress Scales-12(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Response Inhibition by Go/No-Go task(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Alcohol Craving by Penn Alcohol Craving Scale(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Gut Microbiome Composition by 16S rRNA Gene Sequencing(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Working Memory by n-back task(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Drinking Behaviour by Loughborough Alcohol Drinking Questionnaire(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Attention by Visual Search task(From enrollment to the end of the treatment at 4 weeks)
- 38 participants with Alcohol Use Disorder assessed for Cognitive Bias by Rough Estimation Task(From enrollment to the end of the treatment at 4 weeks)
研究者
Kim-Marie Gehrke
Ms
Loughborough University