Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-80
SponsorChangi General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
This single centre study at Changi General Hospital will enrol up to 65 patients aged 21 to 80 years with symptomatic gallstone disease and/ or bile duct stones who will be undergoing cholecystectomy with or without concomitant ERCP-ES as part of standard clinical treatment. There will not be stratification by demographics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Gut microbiome profile using metagenomic shotgun sequencing
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.
Time frame
1-6 months2
Systemic metabolome profile using targeted and untargeted metabolomic analysis
Urine, plasma and saliva samples will be collected for metabolomic profiling prior to and 1-6 months after cholecystectomy.
Time frame
1-6 monthsSecondary outcomes
1
Bile microbiome profile using metagenomic shotgun sequencing
Bile samples will be collected for microbial DNA extraction ERCP and endoscopic sphincterotomy
Time frame
1-6 monthsSponsors and contacts
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Source ClinicalTrials.gov