Influence of Gut Microbiome in Gallstone Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEast Kent Hospitals University NHS Foundation Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients less than 18 years of age and patients who do not have capacity to consent to involvement in the study.
Trial population
Patients with gallstone disease presenting to an East Kent University Foundation Trust Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Bacterial DNA profile
The diversity of species present in the stool of participants
Time frame
through study completion, up to 3 years from cholecystectomySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov