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Studies

Observational Recruiting

NCT05689255 on ClinicalTrials.gov

Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions

Official title: A Prospective Cohort Study of Translational Changes in Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions

  • Sponsor: Changi General Hospital
  • Enrollment: 65 (Estimated)
  • Study start: 2022-12-23 (Actual)
  • Primary completion: 2026-12-31 (Estimated)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The goal of this longitudinal observational cohort study is to examine the changes in the composition and diversity of gut microbiome and systemic metabolome in patients with symptomatic gallbladder stones with or without concomitant common bile duct (CBD) stones who will be undergoing cholecystectomy with or without prior endoscopic sphincterotomy (ERCP-ES) and CBD stones extraction. The main questions it aims to answer are whether there are:

* differences in gut microbiome diversity and composition before and after cholecystectomy
* differences in systemic metabolome before and after cholecystectomy
* gut microbiome and systemic metabolome changes after cholecystectomy

Participants will be asked to provide stool, urine, plasma and saliva samples prior to and 1-6 months after cholecystectomy. For patients with concomitant CBD stones who undergo ERCP-ES before cholecystectomy, bile specimens will be collected from the bile duct during ERCP-ES as well as the gallbladder and/or during cholecystectomy.

Conditions

  • Gallstone Disease
  • Bile Duct Diseases

Primary Outcome Measures

  • Gut microbiome profile using metagenomic shotgun sequencing (1-6 months)
    Fresh stool samples will be collected for microbial DNA extraction prior to and 1-6 months after cholecystectomy. Microbial DNA will be extracted from the stool samples and used for metagenomic shotgun sequencing.
  • Systemic metabolome profile using targeted and untargeted metabolomic analysis (1-6 months)
    Urine, plasma and saliva samples will be collected for metabolomic profiling prior to and 1-6 months after cholecystectomy.

Countries

Singapore

Locations and Investigators

  • Changi General Hospital, Singapore, Singapore (Recruiting)
    • Siok Luan Ong
    • Andrew Siang Yih Wong
    • Andrew Boon Eu Kwek
    • Adrian Kah Heng Chow
    • Nita Thiruchelvam
    • Jinlin Lin
    • Annalisa Ya-Lyn Ng
    • James Weiquan Li
    • Daphne Shih Wen Ang
    • Yu Jun Wong
    • Chin Kimg Tan
    • Kenneth Weicong Lin
    • Nicholas Tee
    • Amanda Huimin See
    • Seok Hwee Koo

Study Officials