Actively Recruiting
Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
Led by Changi General Hospital · Updated on 2026-04-09
65
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 years to 80 years
- Diagnosed with symptomatic gallstone disease with or without bile duct stones confirmed by imaging (ultrasound, CT, MRI, or endoscopic ultrasound)
- Scheduled for gallbladder removal surgery (cholecystectomy) with or without prior endoscopic sphincterotomy (ERCP-ES) for treatment
- Willing to provide informed consent before joining the study
You will not qualify if you...
- Undergoing ERCP-ES without plans for future gallbladder removal surgery
- Used antibiotics or probiotics within 1 month prior to the study (except antibiotics within 48 hours before surgery or ERCP)
- Diagnosed with cancer within the last year
- Had previous stomach, appendix, small bowel, or large bowel surgery
- Diagnosed with inflammatory bowel disease
- Have active infections in the gastrointestinal tract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changi General Hospital
Singapore, Singapore, Singapore, 529889
Actively Recruiting
Research Team
S
Seok Hwee Koo
CONTACT
N
Nway Nway Aye
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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