Clinical trial · Observational
Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Diseases | — | UNRESOLVED | — |
| Dysbiosis | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Microbiota | — | UNRESOLVED | — |
| Pancreatic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients who will undergo ERCP (case group)
- label
- Living liver transplantation donors (control group)
Primary outcomes (1)
- measure
- Composition of the biliary microbiota
- timeFrame
- 2 years
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNascimento 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 33211762