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

NCT05689255 | Recruiting

• 1 other identifier: GMM1
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 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

Gallstone Disease; Bile Duct Diseases

Keywords

microbiome; metabolome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1-6 months

Secondary Outcomes (1)

• Bile microbiome profile using metagenomic shotgun sequencing

  1-6 months

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

RECRUITING

Related Publications (4)

• 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.

  PMID: 8658039 BACKGROUND

• Di 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.

  PMID: 29706426 BACKGROUND

• Chen 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.

  PMID: 28892095 BACKGROUND

• Latenstein 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.

  PMID: 32352682 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool, plasma, urine and saliva before and after cholecystectomy; and bile following ERCP and endoscopic sphincterotomy

MeSH Terms

Conditions

Cholelithiasis; Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Tiing Leong Ang

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Hwee Koo

CONTACT

+6568504929; seok_hwee_koo@cgh.com.sg

Nway Nway Aye

CONTACT

+6569365737; nway_nway_aye@cgh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: January 19, 2023
• Study Start: December 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)