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

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391426
• Other study ID #: 29547920.9.0000.0068
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Dysbiosis
• Early Detection of Cancer
• Microbiota
• Pancreatic Diseases

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