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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Changi General Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Tiing Leong Ang — Changi General Hospital
• Study coordinator: Seok Hwee Koo
• Email: seok_hwee_koo@cgh.com.sg
• Phone: +6568504929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.