肝胆胰疾病患者与健康人群胆汁微生物群分析对比研究（MICROBILIO）：研究方案。
Analysis of biliary MICRObiota in hepatoBILIOpancreatic diseases compared to healthy people [MICROBILIO]: Study protocol.
机构信息
Faculty of Medicine FMUSP, University of São Paulo, São Paulo, São Paulo, Brazil.
Santa Marcelina Faculty, São Paulo, São Paulo, Brazil.
出版信息
PLoS One. 2020 Nov 19;15(11):e0242553. doi: 10.1371/journal.pone.0242553. eCollection 2020.
BACKGROUND
The performance of the microbiota is observed in several digestive tract diseases. Therefore, reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases.
METHODS
Bile samples will be collected in endoscopic retrograde cholangiopancreatography patients (case group) and living liver transplantation donors (control group). We will characterize the microbiome based on two types of sequence data: the V3/V4 regions of the 16S ribosomal RNA (rRNA) gene and total shotgun DNA. For 16S sequencing data a standard 16S processing pipeline based on the Amplicon Sequence Variant concept and the qiime2 software package will be employed; for shotgun data, for each sample we will assemble the reads and obtain and analyze metagenome-assembled genomes.
RESULTS
The primary expected results of the study is to characterize the specific composition of the biliary microbiota in situations of disease and health. In addition, it seeks to demonstrate the existence of changes in the case of illness and also possible disease biomarkers, diagnosis, interventions and therapies in hepatobiliopancreatic diseases.
TRIAL REGISTRATION
NCT04391426. Registered 18 May 2020, https://clinicaltrials.gov/ct2/show/NCT04391426.
背景
微生物群的表现可在几种消化道疾病中观察到。因此，到达胆汁微生物群可能为肝胆胰疾病的生物标志物研究、诊断、检测和治疗提供思路。
方法
将在经内镜逆行胰胆管造影术患者（病例组）和活体肝移植供体（对照组）中收集胆汁样本。我们将基于两种类型的序列数据来描述微生物组：16S 核糖体 RNA（rRNA）基因的 V3/V4 区和总鸟枪法 DNA。对于 16S 测序数据，将采用基于扩增子序列变异概念和 qiime2 软件包的标准 16S 处理流水线；对于鸟枪法数据，对于每个样本，我们将组装读取内容，并获得和分析宏基因组组装基因组。
结果
该研究的主要预期结果是描述疾病和健康状态下胆汁微生物群的特定组成。此外，它旨在证明在患病情况下存在变化，以及在肝胆胰疾病中可能存在的疾病生物标志物、诊断、干预和治疗方法。
试验注册
NCT04391426。注册于 2020 年 5 月 18 日，https://clinicaltrials.gov/ct2/show/NCT04391426。
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