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

Recruitingn/aAges 21 Years - 80 YearsAllChangi General Hospital
NCT05689255 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 spe

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 21 years to 80 years * Diagnosis of symptomatic gallstone disease without or with concomitant bile duct stones based on prior diagnostic radiological imaging such as transabdominal ultrasound (US), computed tomography (CT), magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS). * Will be scheduled for cholecystectomy with or without concomitant ERCP-ES for treatment. * Patient is willing to provide informed consent before enrolment in the study. Exclusion Criteria: * Subjects undergoing ERCP-ES with no intention for future cholecystectomy * Use of antibiotics or probiotics within 1 month (exception: use of antibiotics within 48 hours of cholecystectomy or ERCP, as metagenomics will be able to sequence both dead and live bacteria, and marked compositional change is not expected within this time frame) * Presence of malignancy diagnosed within the last 1 year * Previous gastrectomy, appendicectomy, small bowel or large bowel surgery * Inflammatory bowel disease * Active gastrointestinal tract infections
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What it tests

  • Not listed
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Where

1 site
Changi General Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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