Gut bacteria and body metabolites before and after gallbladder and bile duct stone procedures

A Prospective Cohort Study of Translational Changes in Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions

We will see if the mix of gut bacteria and metabolites in stool, blood, urine and saliva changes before and 1–6 months after cholecystectomy (with or without ERCP) in adults with symptomatic gallstones.

Quick facts

• Study type: Observational
• Enrollment: 65 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Changi General Hospital (other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT05689255 on ClinicalTrials.gov

What this trial studies

This is a longitudinal observational cohort of adults with symptomatic gallstones, with or without common bile duct stones, who are scheduled for cholecystectomy with or without prior ERCP-ES. Baseline stool, urine, plasma and saliva samples are collected prior to surgery and again at a scheduled clinic review 1–6 months after cholecystectomy; bile and gallbladder samples will be collected when ERCP-ES and cholecystectomy are performed. Clinical data on post-cholecystectomy symptoms including post-cholecystectomy syndrome and diarrhoea will be recorded, and microbiome and metabolome profiles will be compared over time and against matched controls from other cohorts. Metagenomic sequencing and metabolomic assays will be used to characterise compositional and diversity changes in microbial and systemic metabolic profiles.

Who should consider this trial

Good fit: Adults aged 21–80 with symptomatic gallstones (with or without common bile duct stones) who are scheduled for cholecystectomy and are willing to provide stool, urine, blood and saliva samples and give informed consent.

Not a fit: Patients who recently used antibiotics or probiotics within one month, those with recent malignancy or prior major gastrointestinal surgery, or those undergoing ERCP with no planned cholecystectomy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this work could identify microbial or metabolic signatures that predict post-cholecystectomy symptoms and help tailor follow-up or preventive care.

How similar studies have performed: Previous observational work has reported associations between gut or biliary microbiome patterns and gallstone disease, but longitudinal studies linking post-cholecystectomy microbiome and systemic metabolome changes are limited.

Eligibility criteria

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

Where this trial is running

Singapore, Singapore

• Changi General Hospital — Singapore, Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Tiing Leong Ang — Changi General Hospital
• Study coordinator: Seok Hwee Koo

Conditions: Gallstone Disease, Bile Duct Diseases, microbiome, metabolome