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Understanding changes in the gut microbiome in patients with gallstone disease and its impact on patient outcomes

NCT ID NCT05732480

NEW Sponsor: East Kent Hospitals University NHS Foundation Trust Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with gallstone disease presenting to an East Kent University Foundation Trust Hospital

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

acute cholecystitis gallstones pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute cholecystitis Gall stone Gall stones, common bile duct Pancreatitis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • EKHUFT

    RECRUITING

    Ashford, Kent, TN24 0LZ, United Kingdom

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