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

摘要 这是对R01AA027972的补充申请，标题为“人群中减少酒精的混合试验” 印度结核病和艾滋病（HATHI）。拟议的研究与母研究目标（目标2）有关， 研究减少饮酒对结核病治疗结果的有效性。在本附录的目标1中，我们 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。此外，作为 目标2的结果是结核病治疗的依从性，我们建议通过一个目标来评估依从性 除了HATHI中已经使用的主观问卷外，还使用了其他测量方法（尿INH试纸）。在aim中 根据本补充文件第2条，我们建议收集血液和粪便样本，以创建生物储存库。这 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， 这将有助于我们了解肠道微生物组和代谢组是否是肠道微生物与代谢物之间的潜在介质。 高酒精摄入量与结核病治疗不良结果之间的关系。总之，这 这项研究将补充母研究的目标，同时增加评估以下方面的宝贵新途径： 潜在的可修改的调解人。

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.