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

摘要 这是对 R01AA027972 的补充请求，标题为“人们减少酒精的混合试验” 印度结核病和艾滋病毒感染者 (HATHI)”。拟议的研究与家长研究目标（目标 2）相关，旨在 检查减少饮酒对结核病治疗结果的有效性。在本增补的目标 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，作为其中之一 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 中已经使用的主观问卷之外，还采取了其他措施（尿液 INH 试纸）。瞄准目标 在本补充文件的第 2 条中，我们建议收集血液和粪便样本以创建生物样本库。这个 将允许未来的研究（例如 R01 研究）进一步为母研究的目标 2 提供信息。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 观察高酒精摄入量与不良结核病治疗结果之间的关系。综上所述，这 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。

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.