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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04391426
Other study ID # 29547920.9.0000.0068
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2021
Est. completion date January 16, 2024

Study information

Verified date September 2021
Source University of Sao Paulo
Contact Alberto Meyer, PhD
Phone +55(11)2661-3323
Email alberto.meyer@usp.br
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 16, 2024
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Brazil University of Sao Paulo School of Medicine Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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