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

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.

NCT Number	NCT05689255
Lead Sponsor	Changi General Hospital
Conditions	Gallstone Disease, Bile Duct Diseases
Enrollment	65 participants
Start Date	2022-12-23
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-09