NCT04391426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

June 3, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2024

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

April 25, 2020

Last Update Submit

September 27, 2021

Conditions

Pancreatic DiseasesMicrobiotaEarly Detection of CancerDysbiosisBiliary Tract Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients who will undergo ERCP (case group)

Living liver transplantation donors (control group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary care adult patients with hepatobiliopancreatic diseases compared to healthy people, that are living donors of liver transplant

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo School of Medicine

São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33211762DERIVED

MeSH Terms

Conditions

Pancreatic DiseasesDysbiosisBiliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Alberto Meyer, PhD

CONTACT

+55(11)2661-3323alberto.meyer@usp.br

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2020

First Posted

May 18, 2020

Study Start

June 3, 2021

Primary Completion

January 1, 2023

Study Completion

January 16, 2024

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

BR(1)