Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction of dysbiosis from day 1 to day 90
研究概览
简要总结
This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a 2x2 design in which subjects will be randomly assigned to one of 4 interventions groups: tVNS and probiotic (n=20); tVNS and placebo (n=20), sham stimulator and probiotic (n=20), and sham stimulator and placebo (n=20). We will use a computer-assisted stratified block randomization with block size of 4 to assign participants to the intervention. Study participants, investigators, staff, and physicians administering the probiotics or placebo will be unaware of specific group assignment. The stratified, blocked randomization and assignment of participants to the 4 intervention groups will be guided and monitored by Data Science Core.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-70 years
- •English or Spanish speaking
- •Alcohol users
- •Cognitive impairment
- •Current CD4>350
排除标准
- •Diagnosed major psychiatric illness
- •Consumption of over 300 drinks in the past 30 days
- •Recent opioid use
- •Lifetime history of medically-assisted alcohol detoxification
- •Inpatient or intensive treatment for addictive behaviors in the past 12 months
- •MRI contraindications
- •Current antibiotic treatment
- •Current probiotic use
- •Physical impairment precluding motor response or lying still.
研究组 & 干预措施
Device (including sham)
Transcutaneous Vagal Nerve Stimulation (tVNS)
干预措施: Transcutaneous Vagal Nerve Stimulation (tVNS) (Device)
Dietary Supplement (e.g., vitamins, minerals)
Visbiome probiotic supplement
干预措施: Probiotic Supplement (Dietary Supplement)
结局指标
主要结局
Reduction of dysbiosis from day 1 to day 90
时间窗: Baseline up to 90 days
The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria.
Improved cognition from day 1 to day 90
时间窗: Baseline up to 90 days
Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.
次要结局
未报告次要终点