Analysis Of Biliary Microbiota In Hepatobiliopancreatic Diseases Compared To Healthy People [MICROBILIO]

Study Overview

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

The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.

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Pancreatic Diseases
Microbiota
Early Detection of Cancer
Dysbiosis
Biliary Tract Diseases

29547920.9.0000.0068

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-04-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-09-27
First Submitted that Met QC Criteria 2020-05-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-09-28
First Posted (ACTUAL) 2020-05-18	Results First Posted N/A	Last Verified 2021-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Patients who will undergo ERCP (case group)
: Living liver transplantation donors (control group)

Primary Outcome Measures	Measure Description	Time Frame
Composition of the biliary microbiota	In this study, the investigator's objective will be to characterize the specific composition of the biliary microbiota in patients with hepatobiliopancreatic diseases in comparison with healthy people using 16S ribosomal RNA (rRNA) pyrosequencing methods.	2 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Alberto Meyer, PhD

Phone Number: +55(11)2661-3323

Email: alberto.meyer@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Patients over 18 years old complete
Patients previously scheduled for ERCP
Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla

Patients over 18 years old up to 55 years
Previously selected patients with scheduled surgery
BMI: 18 kg / m² to 28 kg / m²
Blood typing identical to the recipient
Absence of significant medical, psychiatric problems or previous abdominal surgery
Normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis B, C and HIV
Normal imaging exams: CT of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), MRI with cholangioresonance

ERCP candidates (case group)

Use of antibiotics during ERCP or in the last 2 months prior to the procedure
Emergency ERCP
Pregnancy
Uncorrected coagulopathy

Use of antibiotics in the last 2 months prior to the procedure
Pregnancy
Uncorrected coagulopathy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Nascimento FSD, Suzuki MO, Taba JV, de Mattos VC, Pipek LZ, D'Albuquerque EMC, Iuamoto L, Meyer A, Andraus W, Pinho JRR, de Moura EGH, Setubal JC, Carneiro-D'Albuquerque LA. Analysis of biliary MICRObiota in hepatoBILIOpancreatic diseases compared to healthy people [MICROBILIO]: Study protocol. PLoS One. 2020 Nov 19;15(11):e0242553. doi: 10.1371/journal.pone.0242553. eCollection 2020.

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Clinical Trial Record