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

Sponsor
University of Sao Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04391426
Collaborator
(none)
100
Enrollment
1
Location
31.4
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
    Actual Study Start Date :
    Jun 3, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 16, 2024

    Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Composition of the biliary microbiota [2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group)

    • 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

    Liver transplant living-donor (control group)

    • 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

    Exclusion Criteria:

    • ERCP candidates (case group)

    • Use of antibiotics during ERCP or in the last 2 months prior to the procedure

    • Emergency ERCP

    • Pregnancy

    • Uncorrected coagulopathy

    Liver transplant living-donor (control group)

    • Use of antibiotics in the last 2 months prior to the procedure

    • Pregnancy

    • Uncorrected coagulopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Sao Paulo School of Medicine Sao Paulo Brazil 05403-000

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alberto Meyer, MD PhD FACS, Principal Investigator, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT04391426
    Other Study ID Numbers:
    • 29547920.9.0000.0068
    First Posted:
    May 18, 2020
    Last Update Posted:
    Sep 28, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Diseases
    Biliary Tract Diseases
    Dysbiosis

    Study Results

    No Results Posted as of Sep 28, 2021