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Cognitive and Inflammation Targeted Gut-Brain Interventions in People Living with HIV who are High-Risk Alcohol Users

对高危饮酒者艾滋病毒感染者进行认知和炎症针对性肠脑干预

基本信息

批准号：
10304326
负责人：
Eric Porges
金额：
$ 40.3万
依托单位：
UNIVERSITY OF FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-10 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10304326
关键词：
Activities of Daily Living Address Alcohol consumption Alcohols Anti-Cholinergics Anti-Inflammatory Agents Bacteria Biological Biological Markers Blood Brain Cardiovascular system Cognition Cognitive Data Data Science Core Enrollment Evaluation Functional Magnetic Resonance Imaging Functional disorder Glutathione Goals HIV HIV Infections Health Heavy Drinking Hepatitis Homeostasis Human Hybrids Impaired cognition Impairment Inflammation Inflammatory Intervention Intervention Studies Intestinal permeability Link Liquid substance Liver diseases Machine Learning Measures Nerve Neurocognition Neurocognitive Obesity Outcome Parasympathetic Nervous System Participant Pathogenicity Pathologic Pathway interactions Peripheral Persons Phase Placebos Postdoctoral Fellow Prevalence Probiotics Process Property Public Health Quality of life Randomized Randomized Clinical Trials Research Research Infrastructure Research Personnel Rest Risk Behaviors Serum System Testing Therapeutic Therapeutic Effect Training Programs United States National Institutes of Health Vagus nerve structure Viral Load result acceptability and feasibility alcohol effect alcohol research alcohol risk antiretroviral therapy biological adaptation to stress brain dysfunction brain health cell motility clinically significant co-infection cognitive function cognitive testing comorbidity cytokine design dysbiosis effective intervention fecal microbiome functional improvement gamma-Aminobutyric Acid gastrointestinal gut dysbiosis gut microbiome gut-brain axis high risk high risk sexual behavior immune function improved indexing microbial microbiome composition microbiota-gut-brain axis mortality neural network neuroimaging neuroinflammation pre-doctoral probiotic supplementation reconstitution relating to nervous system scale up systemic inflammatory response transmission process treatment adherence vagus nerve stimulation viral transmission

项目摘要

RC2 Summary The overarching goal of Research Component 2 (RC2) is to determine whether two non-invasive biological interventions, transcutaneous vagal nerve stimulation (tVNS) and a probiotic supplementation intervention (PBI), will improve cognitive and brain functioning, systemic and neuroinflammation, and gut microbiome health in people living with HIV (PWLH) who are high risk users of alcohol. The study will also delineate mechanisms of the gut-brain axis, which is particularly relevant, given that the factors underlying adverse cognitive and brain effects of alcohol use among PLWH remains unresolved. There is also considerable public health significance if beneficial effects of tVNS and/or PBI can be demonstrated, as cognitive disturbances that adversely impact health outcomes, functional abilities and quality of life are common (~ 50% prevalence), despite marked reductions in mortality in the era of antiretroviral therapies (ART). Among PLWH with reconstituted immune function and undetectable viral loads, comorbid conditions remain common and can have adverse functional consequences. High risk alcohol use, prevalent among PLWH, not only contributes to cognitive and brain dysfunction, but also further exacerbates comorbidities (e.g. liver disease, hepatitis coinfection, obesity, and cardiovascular and gastrointestinal dysfunction), and reduces treatment adherence while increasing the propensity for high risk sexual behaviors, worse health outcomes, and transmission of the virus. The study’s clinical significance is strong given the need for effective interventions to improve cognition and health outcomes in PLWH. To test these hypotheses, we will conduct a hybrid randomized clinical trial that will enroll 80 PLWH who are high risk drinkers from our existing research infrastructure supported by the Southern HIV Alcohol Research Consortium (SHARC). In a 2x2 factorial design, participants will be randomly assigned to one of 4 conditions (tVNS+placebo, sham- stimulaiton+placebo, tVNS+probiotic, sham-stimulation+probiotic). We will obtain data on alcohol consumption, cognitive assessments, blood biomarkers, stool microbiome, and neuroimaging at three timepoints (baseline, 30-days, 90 days).

RC2总结