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NCT05732480
Influence of Gut Microbiome in Gallstone Disease
Conditions: Gall Stone, Gall Stones, Common Bile Duct, Pancreatitis, Acute Cholecystitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 75
Sponsor: East Kent Hospitals University NHS Foundation Trust
Location: EKHUFT Ashford Kent
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.
Source: ClinicalTrials.gov (NCT05732480). StuddyBuddy aggregates publicly available trial information.