Viewing Study NCT05592795


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Study NCT ID: NCT05592795
Status: UNKNOWN
Last Update Posted: 2023-03-20
First Post: 2022-10-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Sponsor: Qi-Yong Li
Organization:

Study Overview

Official Title: Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology
Status: UNKNOWN
Status Verified Date: 2023-03
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The objective of this observational study is to explore the structure of biliary flora in normal people, explore the dynamic impact of ERCP and EST on biliary microecology, study the marker flora, metabolites and functional genes related to biliary diseases, explore the occurrence and development mechanism, regulatory pathways and key targets of biliary diseases, and provide new strategies for the prevention and treatment of biliary diseases from the perspective of biliary microecology.
Detailed Description: Our research group applied the technology of macro genome sequencing to explore the biliary microecology through genomics and metabonomics analysis, describe the biliary microecology map of normal people, and build the biliary microecology framework of normal people; To explore the dynamic impact of ERCP and EST treatment on biliary tract microecology, and to further study the dynamic changes, abundance information and diversity characteristics of biliary tract microecology in patients with duodenal papillary incision and Oddi sphincter dysfunction, so as to find the marker flora and metabolites related to bile duct diseases, as well as the prognostic predictive value of specific flora and clinical diagnosis and treatment plan. This study provides a new direction for exploring the composition of human biliary microecology and the occurrence and development mechanism of biliary diseases and provides a new strategy for the treatment of patients with biliary diseases. It has important scientific significance and clinical value.

This project systematically studies the physiological characteristics of biliary tract microecology in normal people, explores the impact of ERCP and EST duodenal papillary incision on biliary tract microecology, clarifies the integrated genomic and metabolomic maps of biliary tract microorganisms in different states, compares the differences of biliary tract microecology at different key nodes, looks for the marker flora related to ERCP and EST treatment, and analyzes the correlation between the marker flora and clinical characteristics, To explore the role and mechanism of key bacteria in the occurrence and development of biliary diseases, so as to provide theoretical basis and strategies for improving prognosis for clinical treatment.

Purpose of this study

1. To construct the framework of biliary microecology in normal people, and define the structure and metabolite characteristics of biliary flora;
2. To study the short-term and long-term changes of biliary microecology in patients with ERCP, EST duodenal papillary incision and Oddi sphincter dysfunction, and explore the influence of specific pathogenic bacteria on the occurrence and development of biliary diseases
3. To screen the key flora of biliary microecology disorder before and after ERCP and EST treatment, and to explore the role and mechanism of marker flora in the occurrence and development of biliary diseases.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: