Clinical trial Recruiting at 1 site Observational Ages 18 and up

Exploring the role of gut microbiome in gallstone disease

Official title: Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes

Run by East Kent Hospitals University NHS Foundation Trust · NCT05732480 · Data updated 2026-11-12

This study looks at how the bacteria in the gut might affect complications from gallstone disease in adults who are having their gallbladder removed.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment75 (estimated)
SponsorEast Kent Hospitals University NHS Foundation Trust
Government
Locations1 site (Ashford, Kent)
StatusRecruiting
StartedMay 30, 2023
Main results expectedNovember 13, 2025
Study endsNovember 13, 2026
Registry record updatedSeptember 9, 2026
Trial IDNCT05732480 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old diagnosed with gallstone disease at East Kent University Hospitals.

Probably not a fit

Patients under 18 years of age or those unable to consent will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While there is limited research on the gut microbiome's role in gallstone disease, preliminary studies suggest potential associations, making this approach novel.

Who can join: the full rules

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 it's running

  • Ekhuft
    Ashford, Kent, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.