Exploring the role of gut microbiome in gallstone disease
Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes
This study looks at how the bacteria in the gut might affect complications from gallstone disease in adults who are having their gallbladder removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East Kent Hospitals University NHS Foundation Trust Government |
| Locations | 1 site (Ashford, Kent) |
| Trial ID | NCT05732480 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between the gut microbiome and gallstone disease complications, such as pancreatitis and acute cholecystitis. Participants will provide stool samples at various time points, including before and after cholecystectomy, to assess changes in their gut microbiome. The study will involve 75 adult patients diagnosed with gallstone disease at East Kent University Hospitals NHS Foundation Trust. Data will be collected from electronic patient records to evaluate patient outcomes related to gallstone disease.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with gallstone disease at East Kent University Hospitals.
Not a fit: Patients under 18 years of age or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of gallstone disease complications through microbiome profiling.
How similar studies have performed: While there is limited research on the gut microbiome's role in gallstone disease, preliminary studies suggest potential associations, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ashford, Kent
- Ekhuft — Ashford, Kent, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Charlotte Burford
- Email: charlotte.burford1@nhs.net
- Phone: +44 1227 766877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.