Impact of alcohol reduction on Tuberculosis drug levels, TB adherence and gut microbiome

减少饮酒对结核病药物水平、结核病依从性和肠道微生物群的影响

• 批准号: 10544859
• 负责人: GEETANJALI CHANDER
• 金额: $ 10.79万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10544859
• 关键词: Adherence; Affect; Alcohol consumption; Alcohols; Biological; Blood specimen; Caring; Cessation of life; Complement; Country; Data; Disease; Effectiveness; Failure; Funding; Future; Goals; Grant; HIV; HIV/TB; Heavy Drinking; Hybrids; Incidence; India; Intervention; Measures; Mediating; Mediator of activation protein; Metabolic Pathway; Metabolism; Outcome; Parents; Participant; Pathway interactions; Persons; Probiotics; Questionnaires; RNA; Rifampin; Risk; Role; Testing; Treatment outcome; Tuberculosis; Urine; alcohol misuse; biobank; drinking; gut dysbiosis; gut microbiome; improved; isoniazid; medication compliance; metabolome; microbiome; stool sample; treatment adherence; treatment as usual; tuberculosis drugs; tuberculosis treatment

ABSTRACT This is a request for supplement to the R01AA027972 titled “Hybrid trial for alcohol reduction among people with TB and HIV in India (HATHI)”. The proposed study is related to the parent study aim (aim 2) that seeks to examine the effectiveness of alcohol reduction on TB treatment outcomes. In aim 1 of this supplement, we propose to assess whether and how the intervention affects TB drug levels during treatment. Further, as one of the outcomes for aim 2 is TB treatment adherence, we propose to assess adherence through an objective measures (urine INH dipstick) in addition to the subjective questionnaires already being used in HATHI. In aim 2 of the this supplement, we propose to collect blood and stool samples in order to create a biorepository. This will allow for future studies (e.g. R01 study) that will further inform aim 2 of the parent study. More specifically, it will help us understand whether the gut microbiome and metabolome are potential mediators between the observed relationship between high alcohol intake and adverse TB treatment outcomes. In summary, this study will supplement the goals of the parent study while adding valuable new avenues for assessments on potential modifiable mediators.

抽象的 这是对 R01AA027972 的补充请求，标题为“人们减少酒精的混合试验” 印度的结核病和艾滋病毒 (HATHI)”。拟议的研究与旨在寻求的家长研究目标（目标 2）相关。 在本补充材料的目标 1 中，我们研究了减少饮酒对结核病治疗结果的有效性。 作为其中之一，建议评估干预措施是否以及如何影响治疗期间的结核病药物水平。 目标 2 的结果是结核病治疗依从性，我们建议通过目标来评估依从性 除了 HATHI In Target 中已经使用的主观问卷之外，还采用了其他措施（尿液 INH 试纸）。 在本补充文件的 2 部分中，我们建议收集血液和粪便样本以创建一个生物样本库。 将允许未来的研究（例如 R01 研究）进一步告知母研究的目标 2 更具体地说， 它将帮助我们了解肠道微生物组和代谢组是否是 观察到的高酒精摄入量与不良结核病治疗结果之间的关系。 研究将补充母研究的目标，同时增加有价值的新评估途径 潜在的可修饰介体。