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

• Conditions: Early Detection of Cancer; Dysbiosis; Pancreatic Diseases; Microbiota; Biliary Tract Diseases

• Registration Number: NCT04391426
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-18
• Study Start: 2021-06-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Sao Paulo School of Medicine; 🇧🇷 Sao Paulo, Brazil