Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]: Study Protocol

Abstract

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). From the DNA extracted from the samples, the microbiomes will be sequenced by 16S ribosomal RNA (rRNA) pyrosequencing methods. Student’s t-test will be performed with SPSS version 20 for Windows and the Mann-Whitney test will be performed using R software and Python scripts. A principal component analysis signals will be developed as discriminative analysis.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.Conclusions: We believe that the investigation of the biliary tract microbiota will provide benefits such as early diagnosis and new treatments. This should improve quality of life and survival, specially in malignant diseases. Thus, this research will give expectations to further investigation in the biliary microbiota.Trial registration: NCT04391426. Registered 18 May 2020, https://clinicaltrials.gov/ct2/show/NCT04391426