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Recruiting NCT05732480

Influence of Gut Microbiome in Gallstone Disease

Trial Parameters

Condition Gall Stone
Sponsor East Kent Hospitals University NHS Foundation Trust
Study Type OBSERVATIONAL
Phase N/A
Enrollment 75
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-30
Completion 2025-11-13

Brief 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.

Eligibility Criteria

Inclusion Criteria: * All adults (age \>18 years of age) patients diagnosed with gallstone disease following confirmatory imaging at an East Kent University Foundation Trust Hospital. Patients of any gender, ethnicity or socio-economic background are eligible as well as pregnant women. Patients undergoing both open and laparoscopic cholecystectomy will be included. Exclusion Criteria: * Patients less than 18 years of age and patients who do not have capacity to consent to involvement in the study.

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