Longitudinal profiling of gut microbiome among tuberculosis patients under anti-tuberculosis treatment in China: protocol of a prospective cohort study
Longitudinal profiling of gut microbiome among tuberculosis patients under anti-tuberculosis treatment in China: protocol of a prospective cohort study
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中国接受抗结核治疗的结核病患者肠道微生物组的纵向分析：前瞻性队列研究方案
DOI：
10.1186/s12890-019-0981-9
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发表时间：
2019-11
影响因子：
3.1
通讯作者：
Xu Biao
中科院分区：
文献类型：
--
作者：
Shi Wenpei;Hu Yi;Zheng Xubin;Ning Zhu;Wu Meiying;Xia Fan;Prast-Nielsen Stefanie;Hu Yue O. O.;Xu Biao
背景抗结核治疗需要至少6个月的治疗，并持续使用联合抗生素，包括异烟肼、利福平、吡嗪酰胺和乙胺丁醇。长期暴露于抗生素可能会导致肠道菌群的变化，这可能会改变患者的胃肠道功能和药物吸收，从而影响治疗结果。该研究的目的是描述结核病（TB）患者在标准化一线治疗下肠道菌群的纵向变化，并了解肠道菌群组成的改变与不利的临床outcomes.MethodsThe研究是一项多中心，观察性前瞻性队列研究。在中国西部（四川省）和东部（江苏省和上海市）有目的地选择了三个研究地点。招募了300名细菌学确诊的肺结核患者。所有符合条件的患者应在治疗开始前使用结构化问卷进行调查;并在治疗期间的第-14天、第-2个月、第-5个月、治疗结束和治疗结束后第6个月进行随访。每次访视时采集粪便样本，包括每例患者的6份粪便样本。此外，将招募来自四川省和上海市的60名健康志愿者作为健康对照，以形成中国人群中患者肠道菌群的基线。从诊断时到治疗完成后第6个月，肠道微生物群在α多样性、β多样性、分类组成方面的动态变化将被单独说明。此外，肠道菌群的多样性和组成部分，将进行比较组之间有和没有不利的治疗结果的不良反应和治疗failure.DiscussionStudies的临床表现，不良反应，肠道菌群的改变将提供科学合理的证据肠道菌群的改变对结核病治疗结果的影响。该研究不仅有助于指导个性化结核病治疗，还有助于了解持续抗生素给药对肠道菌群的影响。试验注册中国临床试验注册中心，试验ID：ChiCTR 1900023369，May 24，2019.已登记的逆行。
BackgroundAnti-tuberculosis therapy requires at least six-month treatment with continuous administration of combined antibiotics, including isoniazid, rifampicin, pyrazinamide, and ethambutol. The long-term exposure to antibiotics could cause consequent changes in gut microbiota, which may alter the gastrointestinal function and drug absorption in patients, thereby affect the outcome of treatment. The study aims to characterize the longitudinal changes of gut microbiota among tuberculosis (TB) patients under standardized first-line treatment and provide an understanding of the association between alterations in gut microbiota composition and unfavorable clinical outcomes.MethodsThe study is a multicenter, observational prospective cohort study. Three study sites are purposively selected in the western (Sichuan Province) and eastern (Jiangsu Province and Shanghai) parts of China. Three-hundred patients with bacteriologically confirmed pulmonary TB are enrolled. All eligible patients should be investigated using structured questionnaires before treatment initiation; and be followed up during the treatment at Day-14, Month-2, Month-5, the end of treatment and the sixth month after ending therapy. Stool samples are to be collected at each visit, consisting of six stool samples from each patient. Additionally, 60 healthy volunteers from Sichuan province and Shanghai city will be recruited as healthy controls to form the baseline of patient gut microbiota in the Chinese population. The dynamic changes of gut microbiota in terms of alpha diversity, beta diversity, taxonomic composition are to be illustrated individually from the time at diagnosis until the sixth month after therapy is completed. Furthermore, the diversity and component of gut microbiota will be compared between the groups with and without unfavorable treatment outcome in terms of adverse effect and treatment failure.DiscussionStudies on the clinical manifestations, adverse reactions, and gut microbiota alterations will provide scientifically-sound evidence on the impact of gut microbiota alterations on TB treatment outcomes. The study is not only useful for guiding personalized TB treatment but also sheds light on the effects of continuous antibiotics administration on gut microbiota.Trial registrationChinese Clinical Trial Registry, trial ID: ChiCTR1900023369, May 24, 2019. Retrospectively registered.
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影响因子：
5.3
作者：
通讯作者：
--
DOI：
10.12659/msm.904682
发表时间：
2017-05-18
期刊：
Medical science monitor : international medical journal of experimental and clinical research
影响因子：
--
作者：
Zhang Y;Wu S;Xia Y;Wang N;Zhou L;Wang J;Fang R;Sun F;Chen M;Zhan S
通讯作者：
Zhan S
影响因子：
12.3
作者：
Lloyd-Price J;Abu-Ali G;Huttenhower C
通讯作者：
Huttenhower C
影响因子：
48
作者：
Callahan BJ;McMurdie PJ;Rosen MJ;Han AW;Johnson AJ;Holmes SP
通讯作者：
Holmes SP
影响因子：
4.8
作者：
Makarenkov, V;Legendre, P
通讯作者：
Legendre, P