Probiotics, Immune Function, and the Brain in Alcohol Consumers

Brown University1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2022年2月24日最近更新: 2024年9月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Brown University
入组人数: 32
试验地点: 1
主要终点: Lipopolysaccharide Binding Protein (LBP)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pilot project is a brief, open-label clinical trial of probiotics as an intervention in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit heavy drinkers to complete an open-label within-subjects trial. The study will investigate effects of probiotics on specific biomarkers in healthy heavy drinkers who currently are not seeking to change their alcohol use (i.e., are non-treatment-seeking).

详细描述

This pilot project is a brief, open-label clinical trial of probiotics as an intervention to reduce systemic and neural inflammation in heavy drinkers. Heavy drinkers who do not yet show significant signs of liver disease also may stand to benefit from probiotics, but no clinical trials to date have addressed this population. This study will recruit 15 non-treatment-seeking heavy drinkers to complete an open-label within-subjects trial. Aim 1 is to demonstrate proof-of-concept for beneficial effects of probiotic use on inflammatory processes. Aim 2 is to examine effects of probiotic use on brain metabolites correlated with neuroinflammation using magnetic resonance spectroscopy. Aim 3 is to gather preliminary data on acceptability and feasibility of the probiotic intervention in non-treatment-seeking heavy drinkers.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•18-64 years old;
•Able to speak and read English well enough to complete study procedures;
•Meets NIAAA guidelines for heavy drinking in the past 30 days.

排除标准

•Chronic disease requiring daily use of medication;
•Seeking or receiving treatment for alcohol/drug use, with exception of smoking cessation;
•Self-reported history of liver disease;
•Antibiotic or probiotic use in past 1 month;
•Positive urine drug test;
•History of fainting, weakness, infection, excessive bruising, or extreme distress from blood draw;
•Safety contraindication for MRI (e.g., ferromagnetic implant in the body, claustrophobia);
•Head trauma with loss of consciousness >10 min;
•Pregnant, breastfeeding, or not using effective birth control;
•Unable to complete the study visits due to time or scheduling constraints;
•Weight <110 lbs.
•Conditions of immunodeficiency, such as HIV infection, primary immune deficiency, or taking immune-suppressant medications.

研究组 & 干预措施

Probiotic Arm

Experimental

Probiotic arm

干预措施: Seed DS-01 Daily Synbiotic (Dietary Supplement)