Gallstone DiseaseNCT05689255
Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
An observational study of Gallstone Disease and Bile Duct Diseases, run by Changi General Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Gallstone Disease, Bile Duct Diseases
- How many people
- 65 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Dec 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, Singapore, 529889
Siok Luan Ong, +65-64267280, ong.siok.luan@singhealth.com.sg
Andrew Siang Yih Wong
About this study
Official title: A Prospective Cohort Study of Translational Changes in 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.
Read the detailed description
This is a longitudinal observational cohort study that will examine the changes in the composition and diversity of gut microbiome and systemic metabolome in patients with symptomatic gallbladder stones with or without concomitant CBD stones who will be undergoing cholecystectomy with or without prior ERCP-ES and CBD stones extraction.
Patients with symptomatic gallstones with or without CBD stones being planned for cholecystectomy will be recruited from both inpatient and outpatient settings. Upon enrolment, baseline clinical characteristics will be recorded, and biospecimens (stool, urine, plasma and saliva) will be collected prior to cholecystectomy for subsequent gut microbiome and systemic metabolome analysis. 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 during cholecystectomy, for subsequent bile microbiome analysis. After cholecystectomy, during the scheduled clinic review at 1 to 6 months post-surgery, patients will be reviewed for symptoms of post cholecystectomy syndrome (PCS) or post cholecystectomy diarrhoea (PCD), and biospecimens (stool, urine, plasma and saliva) will again be collected for subsequent gut microbiome and systemic metabolome analysis. The microbiome profile of the study cohort will be compared at baseline with matched controls from other defined cohorts. Post cholecystectomy, the study cohort will also be compared with matched cohort with cholecystectomy duration of more than 12 months.
- Conditions
- Gallstone Disease, Bile Duct Diseases
- Keywords
- microbiome, metabolome
- Medical subject headings
- Cholelithiasis, Bile Duct Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-6 months
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.
Measured: 1-6 months
Secondary outcomes (1)
Bile microbiome profile using metagenomic shotgun sequencing
Bile samples will be collected for microbial DNA extraction ERCP and endoscopic sphincterotomy
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ang Tiing Leong, Changi General Hospital
- Investigators
- Tiing Leong Ang, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689255
- Sponsor's protocol ID
- GMM1
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid FD, Mercer PM, harrison M, Bates T. Cholecystectomy as a risk factor for colorectal cancer: a meta-analysis. Scand J Gastroenterol. 1996 Feb;31(2):160-9. doi: 10.3109/00365529609031981.
PubMed 8658039Di Ciaula A, Garruti G, Wang DQ, Portincasa P. Cholecystectomy and risk of metabolic syndrome. Eur J Intern Med. 2018 Jul;53:3-11. doi: 10.1016/j.ejim.2018.04.019. Epub 2018 Apr 26.
PubMed 29706426Chen Y, Wu S, Tian Y. Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms. Lab Invest. 2018 Jan;98(1):7-14. doi: 10.1038/labinvest.2017.95. Epub 2017 Sep 11.
PubMed 28892095Latenstein CSS, Alferink LJM, Darwish Murad S, Drenth JPH, van Laarhoven CJHM, de Reuver PR. The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study. Clin Transl Gastroenterol. 2020 Apr;11(4):e00170. doi: 10.14309/ctg.0000000000000170.
PubMed 32352682
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Translational Changes in Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
- ClinicalTrials.gov ID
- NCT05689255
- Acronym / sponsor ID
- GMM1
- Conditions
- Gallstone Disease, Bile Duct Diseases
- Keywords
- microbiome, metabolome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a longitudinal observational cohort study that will examine the changes in the composition and diversity of gut microbiome and systemic metabolome in patients with symptomatic gallbladder stones with or without concomitant CBD stones who will be undergoing cholecystectomy with or without prior ERCP-ES and CBD stones extraction.
Patients with symptomatic gallstones with or without CBD stones being planned for cholecystectomy will be recruited from both inpatient and outpatient settings. Upon enrolment, baseline clinical characteristics will be recorded, and biospecimens (stool, urine, plasma and saliva) will be collected prior to cholecystectomy for subsequent gut microbiome and systemic metabolome analysis. 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 during cholecystectomy, for subsequent bile microbiome analysis. After cholecystectomy, during the scheduled clinic review at 1 to 6 months post-surgery, patients will be reviewed for symptoms of post cholecystectomy syndrome (PCS) or post cholecystectomy diarrhoea (PCD), and biospecimens (stool, urine, plasma and saliva) will again be collected for subsequent gut microbiome and systemic metabolome analysis. The microbiome profile of the study cohort will be compared at baseline with matched controls from other defined cohorts. Post cholecystectomy, the study cohort will also be compared with matched cohort with cholecystectomy duration of more than 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome profile using metagenomic shotgun sequencing
Time frame: 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
Time frame: 1-6 months
Urine, plasma and saliva samples will be collected for metabolomic profiling prior to and 1-6 months after cholecystectomy.
1 secondary outcome
Bile microbiome profile using metagenomic shotgun sequencing
Time frame: 1-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 8658039Reid FD, Mercer PM, harrison M, Bates T. Cholecystectomy as a risk factor for colorectal cancer: a meta-analysis. Scand J Gastroenterol. 1996 Feb;31(2):160-9. doi: 10.3109/00365529609031981.
- Background: PubMed 29706426Di Ciaula A, Garruti G, Wang DQ, Portincasa P. Cholecystectomy and risk of metabolic syndrome. Eur J Intern Med. 2018 Jul;53:3-11. doi: 10.1016/j.ejim.2018.04.019. Epub 2018 Apr 26.
- Background: PubMed 28892095Chen Y, Wu S, Tian Y. Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms. Lab Invest. 2018 Jan;98(1):7-14. doi: 10.1038/labinvest.2017.95. Epub 2017 Sep 11.
- Background: PubMed 32352682Latenstein CSS, Alferink LJM, Darwish Murad S, Drenth JPH, van Laarhoven CJHM, de Reuver PR. The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study. Clin Transl Gastroenterol. 2020 Apr;11(4):e00170. doi: 10.14309/ctg.0000000000000170.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiing Leong Ang principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone Disease and Bile Duct Diseases, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seok Hwee Koo (+6568504929, seok_hwee_koo@cgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome profile using metagenomic shotgun sequencing (time frame: 1-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689255, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.