Clinical Trial

Influence of Gut Microbiome in Gallstone Disease

Recruiting
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Record status
This record was last updated February 23, 2024 (before its estimated November 13, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease. The main question\[s\] it aims to answer are: * if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis) * if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes. Participants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-02-16; most recent amendment 2024-02-22.
Status change: Not Yet Recruiting → Recruiting 2023-09-08
Trial Details
NCT Number NCT05732480
Lead Sponsor East Kent Hospitals University NHS Foundation Trust
Conditions Gall Stone, Gall Stones, Common Bile Duct, Pancreatitis, Acute Cholecystitis
Enrollment 75 participants
Start Date 2023-05-30
Primary Completion 2025-11-13 (estimated)
Study Completion 2026-11-13 (estimated)
Updated on ClinicalTrials.gov 2024-02-23