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NCT03490383 Clinical Trial

Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP

Microbial Colonization Clinical Trial

Official title:
ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03490383
Other study ID # CBD stone and microbiota
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 16, 2018
Est. completion date April 1, 2023

Study information
Verified date October 2023
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriria in bile in participants without common bile duct stone. The second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. The third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - CBD tumor or CBD calculi Exclusion Criteria: - contraindication for ERCP

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Shang General Hospital Shanghai
China Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary microbiota in bile 16s RNA intraoperative
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